The Institutional Research Board (IRB), Human Research Protection Program, Export Control unit, and the Institutional Animal Care and Use Committee (IACUC) are fully operational and continue to serve the university research community. New and updated information will be added to this guidance as it becomes available.
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IRB and Human Subject Research
The Institutional Research Board (IRB) and Human Research Protection Program are fully operational. New and updated information will be added to this guidance as it becomes available. In addition, the HRPP will email any alerts on updates directly through the UT Knoxville iMedRIS listserv (i.e., those with active accounts in iMedRIS). To ensure you receive these updates, confirm that firstname.lastname@example.org is included in your safe senders list.
UT Knoxville HRPP/IRB Operations
The Human Research Protection Program and Institutional Review Board are fully operational. HRPP staff are working remotely. The IRB will hold its meetings remotely as necessary.
Researchers can contact the staff by email (email@example.com), phone message (865-974-7697), or by contacting an HRPO staff member directly. All phone messages and emails will be answered as soon as possible.
All new applications and amendment requests will be prioritized as follows:
- COVID-19 studies
- Application with funding approval needs
- COVID-19 related changes
- Safety-related changes
- Funding changes
Submitting New Studies
New applications are still being accepted and reviewed. New studies are be screened and routed for IRB review in accordance with our current procedures and timelines. However, these studies are subject to the restrictions currently in effect:
- Newly approved studies with in-person interactions may not begin until further notice.
- Newly approved studies with no in-person participant interaction may begin after receiving IRB approval.
Studies investigating COVID-19/Effects of the COVID-19 Pandemic
For studies investigating COVID-19 and its effects, include COVID-19 in the study title. In-person interactions remain restricted.
Rapid Response Grants
The IRB is currently prioritizing reviews for COVID-19 related studies and applications with funding approval needs.
If a funded (government, industry, or non-profit) study is placed on hold or modified to replace in-person procedures with remote or virtual procedures, follow sponsor guidance and if required, notify the sponsor as soon as is feasible. Alternately, researchers should contact the Office of Sponsored Programs, their program officer or consult the Council On Government Relations (COGR) FAQ Regarding COVID-19’s Impact on Federal Awards.
The current ClinicalTrials.gov guidance on updating a registered study tell us that any research-related changes that are communicated to the subjects (past, ongoing, future) must be added to the study’s ClinicalTrials.gov registration with 30 days after IRB approval of the modification. Additionally, some studies are modifying their research procedures to include COVID-19 related activities. The ClinicalTrials.gov information for the study should be updated to include these new procedures if they are done for research purposes.
In-Person Contact with Research Participants
All research activities involving in-person contact with participants must be postponed. Only research involving in-person contact that is critical to the treatment of a participant’s significant and life-threatening condition may continue at this time. This includes international human research interactions. The university has very few, if any, active studies that meet this threshold. These restrictions are mandatory and will be in effect at least until such time as the safer-at-home orders are lifted.
Essential/Non-essential Research Interactions
Essential research interactions that cannot occur remotely may only be performed in-person if the IRB has made that determination. The IRB determines whether a research interaction is essential.
Essential interactions are those conducted in ongoing therapeutic studies that hold the prospect of direct benefit to the participant. Studies that involve essential interactions are those that are critical to the treatment of the participant’s significant and life-threatening condition or critical to the participant’s safety. Examples include drug, device or other therapeutic intervention studies.
Non-essential interactions are all other interactions with participants. Examples include:
- Behavioral or social science research interactions that are not critical to participant health or well-being.
- Observational study interactions.
- Non-therapeutic interventional study visits intended to improve health, but not for the treatment of a specific disease or condition.
- Therapeutic study visits for conditions that are not life-threatening in the near-term.
If researchers believe their study meets the criteria for essential interaction, and they have a compelling reason for continuing in-person interaction with participants, principal investigators (PIs) may submit a request to the IRB asking for an exception to these restrictions. PIs must describe the compelling justification for the appeal. The restrictions on in-person interactions must be followed for those studies seeking an appeal until such time as an appeal is granted.
The IRB advises researchers to contact an HRPO staff member before submitting an amendment request to appeal these restrictions. UT has very few, if any, studies meeting the criteria for essential interactions. It is the IRB’s expectation that all in-person research procedures have ceased.
To assist us in conducting efficient reviews of amendment requests submitted in response to COVID-19, the IRB asks researchers to consider the following issues and address those applicable to their study their amendment request submission.
- Address if the changes are temporary or permanent.
- Temporary means remote interactions will be used until in-person interactions can resume.
- Permanent changes mean that remote procedures will replace in-person interactions until the study is completed and closed with the IRB.
- Consider if changes include recruitment, participant screening, the informed consent process, interventions, data collection methods, follow-ups, etc.
- When making temporary changes to your study:
- Identify which study activities are being placed on hold and which study activities will continue (some studies may already be approved for some remote procedure that will continue, like online surveys, etc.).
- Do not include specific dates. Instead, state that regular in-person study activities will resume once the UT HRPP/IRB announces that it safe to do so. This will avoid having to submit follow-up amendments or reports should currently predicted end dates be changed.
- If the modifications will require additional materials (to accommodate remote procedures) but you will resume use of the currently approved materials once restrictions are lifted, add materials for the remote procedures, instead of revising previously approved versions, to avoid additional amendments in order to resume the original activities.
- IRB Application – Revise all screens relating to your changes. Below are iMedRIS screens frequently requiring revisions when remote procedures are added, but your study may require changes to different screens. For additional guidance, see UTK’s IRB Application Instructions on the iMedRIS Help menu.
- (925) Study Synopsis – Possible changes to eligibility screening (if after the informed consent procedure for the study), methods for interventions and data collection.
- (1600) Participant Recruitment – Possible changes to how participants are identified, contacted (i.e., informed about the research opportunity), or screened for eligibility (if prior to the informed consent procedure for the study).
- (2000) Risks and Benefits – Possible changes to potential risks to the participants, particularly for projects that collect sensitive and identifiable information. Examples include the introduction of additional informational/confidentiality risks from video recording an interview, or privacy risks of interviewing a domestic abuse victim at their home rather than a neutral location.
- (2800) Privacy and Confidentiality – Possible changes such as using an online survey tool, moving data storage from hard drive to cloud account, etc.
- (3050) Describe Payment – Possible changes in types of compensation and how compensation is provided to participants.
- (3329) Informed Consent – Possible changes include a request to waive the requirement to obtain the participant’s signature (online data collection, interviews, etc.).
- (3440) Consent Process – Possible changes include obtaining a participant’s signed informed through secured electronic mechanism in place of in-person consent procedures.
- Revised or added study materials such as recruitment material, screening scripts or forms, consent forms, intervention materials, data collection instruments, etc.
- Amendment Request form – The iMedRIS screens that are listed below are those are commonly required when adding remote procedures to a study, but screen revision requirements may vary based on your proposed changes.
- (800) UTK General Study/Project Information, Item 1.3
- Check Other Application Changes to address changes in any procedures used.
- If revising an existing consent form, select Revise Currently Approved (English/non-English) Consent Form as applicable to the study.
- If revising existing recruitment material, data collection materials, etc., select Other.
- (810) Revisions of the Study/Project Application, Item 2.1, Rationale for Revision column – List Coronavirus. This will help flag these submissions for review.
- (400) Revisions to English Consent Form(s) – Select yes if applicable to your study.
- (600) Revisions to Non-English Consent Form(s) – Select yes if applicable to your study.
- (900) Other Changes
Communicating the postponement of research activities to participants does not require IRB review or approval.
Permitted Interactions with Research Participants
Procedures that do not require in-person contact with participants can continue as approved in the IRB application. Procedures that are approved involving in-person contact need to be postponed or, if possible, modified to utilize remote procedures.
Depending on the research, a variety of procedures with participants can be conducted remotely. Examples include, but are not limited to, data collection, some interventions, recruiting, screening, consenting, and administering compensation. Remote procedures to consider include online surveys, video conferencing, phone, email, postal mail, etc.
Online Tools and Applications
The IRB strongly recommends using UT-supported platforms when possible. The IRB is familiar with the data protections provided by these resources. Using these resources in lieu of new apps or software will avoid delays in the review process.
- QuestionPro – surveys/questionnaires
- Qualtrics – surveys/questionnaires
- REDCap – through UTHSC (HIPAA compliant)
When selecting electronic tools and applications, confirm it has the needed functionality and features and that those features are activated. Depending on the product, default settings may not automatically activate the features that you intend to use.
Bringing Data Home
There are ways to work with university data at home so long as you adhere to the privacy, confidentiality and data security safeguards approved in your IRB application. Data security changes deviating from the approved IRB application or the researcher’s data security plan must be approved prior to generating, relocating, accessing, or storing the data. There are several UT resources available to enable researchers to work remotely.
- Working and Teaching Remotely
- Virtual Private Network (VPN)
- File Sharing Options for Sensitive Information
- Vault – allows sharing with non-UT collaborators
- File Storage Options for Sensitive Information
- NICS Advanced Computing Facility – SIP (HIPAA compliant)
- REDCap – through UTHSC (HIPAA compliant)
Researchers need to consider the following when moving research operations from campus to remote locations:
- Are the appropriate data security and confidentiality measures in place?
- Is an amendment request required to allow for research activities with study data to be conducted at home or other remote location (such as modifications to data security/storage, impacts on privacy, etc.)?
- Is the use of the research data covered by a data use agreement (DUA) or other contractual obligations (such as a sponsor agreement, etc.)? If so, changes may also require notification and/or amendments to data use agreements or other sponsor agreements.
- If the research data is subject to additional regulatory requirements (FERPA, HIPAA, etc.), does the remote access include all required security safeguards?
Information to include in an amendment or new application when using online tools or applications
- Identify the specific product to be used.
- Some online tools and applications have optional settings/features. When these are used for a study, researchers must state in their IRB application that those features will be activated (e.g., QuestionPro’s anonymize setting).
- If using an audio-video conferencing application, state whether audio or video will be used. Describe if those activities will be recorded. Some applications, like Zoom, allow users to record sessions.
- If using non-UT supported tools and application, describe all security safeguards.
Restrictions on in-person interaction apply to all human subjects research conducted by UT employees, staff or students, even if the study is under review by an External IRB. The research team should notify the External IRB and follow all External IRB requirements for any modifications or reporting that occurs from these restrictions.
Modifying Study Procedures
Some researchers may be able to replace in-person interaction procedures with remote interaction options (phone calls, online surveys, audio-video conferencing, email, postal mail, etc.). Depending on the study, remote procedures can be used for situations like recruitment, eligibility screening, obtaining informed consent, data collection, some interventions, and administering compensation.
For Full Board and Expedited Studies
Submit an amendment request in iMedRIS. Researchers can assist staff by listing Coronavirus as the rationale for the amendment in section 2.0 (200) Revisions of the Study/Project Application of the amendment request form. This will help flag these submissions so we can review them as quickly as possible.
For Exempt Studies Only
Below we list some changes that can be made to exempt research studies without submission of an amendment request. Any changes to exempt studies that are not explicitly listed as not requiring an amendment request must be reviewed and approved by the IRB through an amendment request. We have also included examples of changes that do require an amendment request.
Changes to Exempt Research NOT REQUIRING an Amendment Request:
- Change from in-person survey/questionnaire to an online survey using UT Knoxville’s QuestionPro, Qualtrics, or REDCap (through UTHSC) survey tools AND anonymous data collection (study uses the survey tool’s anonymize setting)
- Change from in-person interviews or focus groups to conducting those activities via Zoom
- Adoption of this screening procedure when conducted solely to determine whether the study visit should take place, be rescheduled, or canceled
Changes to Exempt Research REQUIRING an Amendment Request
- Change from in-person survey/questionnaire to an online survey using a survey tool other than using UT Knoxville’s QuestionPro, Qualtrics, or REDCap (through UTHSC), whether data are collected anonymously or with identifiers
- Change from in-person survey/questionnaire to an online survey collecting identifiers (including IP address), regardless of the survey tool used
- Change from in-person interviews or focus groups to conducting those activities using a video conferencing software/tool other than Zoom
- Any scenario not explicit under the “Changes to Exempt Research Not Requiring an Amendment Request” section above. If you are in doubt, submit an amendment request in iMedRIS.
Modifying Study Procedures Immediately in Order to Protect Study Participants, Researchers, or Others
If it is in the best interest of participants, researchers, or others to eliminate immediate apparent hazards and the researcher is unable to submit an amendment request, the researcher may implement changes without prior IRB approval, but the change must be submitted using a Reportable New Information form (Form 4) within five business days of the change.
Interacting with Research Participants
All researchers (faculty, staff and students) must abide by the following:
- In-person research interactions are on hold until further notice unless the interaction is essential to participants’ health and well-being or their safety.
- Research interactions (both essential and non-essential) performed remotely with participants may continue.
- In-person research interactions that are non-essential are on hold until further notice.
Enrolling New Participants to an IRB-approved Study
- Studies involving no in-person interaction with research participants may continue enrollment.
- Studies involving in-person interactions with research participants must place enrollment on hold until further notice.
If your study was approved under exempt review and the changes meet the criteria identified above, then submission for review and approval is not required.
Changes can be made to eliminate apparent immediate hazards to participants without prior IRB review and approval. However, the change must be reported to the IRB by submitting Reportable New Information form (Form 4) in iMedRIS within five (5) business days of the change.
Recruitment, enrollment and data collection
The distinctions between these three processes are slightly different and need to be treated as such. The terms are defined as follows:
· Recruitment: A range of activities involving identifying populations eligible for research participation and providing them with information about the research study through fliers, newspaper advertisements, social media posts, etc.
· Enrollment: The act or process of verifying an individual’s eligibility to participate in a research study and obtaining their informed consent.
· Data collection: The process of gathering and measuring information on variables of interest that enables one to answer stated research questions, test hypotheses, and evaluate outcomes.
When researchers must postpone activities or place entire studies on hold, study records should reflect the mandated restrictions. A report to the IRB is required only if one or more of the following apply to your study.
- Studies required to obtain continuing review should identify which activities were postponed/placed on hold in the continuing review request and explain the reason (i.e., COVID-19 related restrictions).
- Studies suspended at the request of an external funding agency or the study’s Data Safety Monitoring Board, if there is one, should submit a Reportable New Information form.
Informed consent is usually documented in writing and signed by the participant. Under some circumstances, the IRB can waive the requirement to obtain the participant’s signature (i.e., waiver of documentation of consent).
Consent Methods Not Requiring a Participant’s Signature
For research approved by expedited or full board review, a waiver of signed consent may be an option. The waiver of signed consent requires that a consent process be conducted with participant, but does not require the participant to provide written documentation of that process. Although the regulations allow for a few different ways that research may qualify for this waiver, this FAQ discusses the option most applicable to the adoption of remote procedures. A study may qualify for this waiver if the research:
- presents no more than minimal risk of harm to participants, and
- involves no procedures for which written consent is normally required outside of the research context (i.e., research involving activities subject to other laws that require a person’s signed consent, such as HIPAA or FERPA, is not eligible for this waiver).
When the IRB approves a waiver of signed consent studies eligible for this waiver frequently use either verbal consent or implied consent.
Verbal consent means that the individual obtaining consent reads/explains a verbal version of a consent form (i.e. an information sheet or consent statement), and participants give their verbal consent in place of written consent to participate. Participants should be provided with a copy of the information sheet and given the opportunity to ask questions. If it is not feasible to provide subjects with an information sheet — for example, the only contact is by phone – submit a consent script with your amendment request.
The IRB recommends that researchers document in the research records when the consent discussion took place and if there were any issues.
Many studies, such as survey research, provide consent information to prospective participants. Those participants do not typically express their consent directly to the researchers, instead their consent is implied through their choice to return a completed survey to the researchers. Implied consent may occur in both electronic and face-to-face settings, or through regular mail. Online survey studies often include the consent information at the beginning of the survey and participants are asked to click “Agree” or “Continue” if they wish to participate, but consent is still implied because participants do not actually “agree” until they submit or return their completed survey.
Obtaining Signed Consent
Signed consent can be obtained by sending the consent form to prospective participants through U.S. mail, email, fax, a file sharing application (e.g., UT’s Vault), etc. If the participant chooses to enroll in the study, they need only sign and return the consent form to the researchers.
Obtaining an Electronic Signature
Electronic signatures are often a source of confusion. To satisfy human research regulatory requirements for written consent, the following criteria must be incorporated into the electronic form.
- a valid electronic signature must be obtained (see definition below);
- the participant must be able to print (or save) a copy of the consent form (with or without signature); and
- include instructions to print or save a copy of the page presented on the electronic device unless the form will be provided to the participant by an alternative means.
Definition of a Valid Electronic Signature Standards
A valid electronic signature for consent could be the participant’s typed name or it could even be as simple as a check mark or an X or any other symbol in a box on a form. Any method is valid provided that the mark or symbol is “logically associated” with the individual making that mark. To associate the individual to the mark, the participant could type their name or even be assigned a unique ID number.
Researchers need to be aware of relevant laws pertaining to electronic signatures in the jurisdiction where the research is going to be conducted and communicate those requirements to the IRB. For example, research activities subject to FERPA, HIPAA, FDA, etc. may be subject to additional requirements.
Researchers proposing to obtain a participant’s electronic signature (in lieu of a written signature) should provide the IRB with information about
- how the electronic signature is being created,
- if the signature can be shown to be legitimate, and
- if the consent or permission document can be produced in hard copy for review by the potential participant.
One method of allowable electronic signatures in some jurisdictions is the use of a secure system for electronic or digital signature that provides an encrypted identifiable “signature.” For example, DocuSign or other system that authenticates the user.
Researchers must describe how the consent process will be conducted. For some studies it is sufficient to request participants to contact the researcher with any questions. For other types of studies, it may be necessary for the researchers to include a process to discuss the study with participants and address their questions.
Copy of Consent Document
In all cases, some form of the consent document must be made available to participants in a format they can retain.
Privacy, Confidentiality and Data Security
Researchers should describe any related protections that will be used
Caring for Laboratory Animals
In coordination with University leadership, the Institutional Animal Care and Use Committee (IACUC) and the Office of Laboratory Animal Care (OLAC) strongly recommend that faculty, staff and students take a proactive approach and develop plans to ensure that you are prepared to care for your animals and to safeguard your research projects in the event that the evolving status of COVID-19 leads to a disruption in research activities/access and staffing.
It is imperative that investigators have contingency plans in their labs for ongoing research protocols and any unique care requirements for their research animals. Items to address and consider include:
- A plan for ongoing non-routine care requirements for animals currently on study (e.g. special diets, post-surgical care, special housing).
- The impact of truncated study timelines or data collection. Consider delaying initiation of protocols with long study durations.
- Addressing any staffing concerns for ongoing studies through cross-training and personnel amendments.
- Updating all contact information to prepare for potential personnel absences.
- Updating contact information for members of the lab authorized to make decisions in the event of an emergency related to your animal work. This contact information should be readily available in your workspace within the lab animal facilities (LAF) in the event that someone who is not familiar with the facility needs additional information.
Personnel working in our dedicated LAFs are considered essential and will continue to provide animal care. Please note that while the LAF staff will continue with basic, essential husbandry practices (i.e. cage changes, cleaning, feeding), in the event of reduced staffing, they will not be able to provide extra services (i.e. weaning mice, enrichment, etc.). The husbandry staff cannot engage in protocol-specific research activities. Additionally, OLAC staff will not be able to provide research-specific services should the LAFs experience staffing issues, as they will be providing husbandry support as required.
Contingency plans are also in place to manage animal care at our Research and Education Centers (RECs) in east and middle Tennessee. Personnel not normally tasked with animal care are undergoing training to assume basic husbandry responsibilities, should this prove necessary. Please contact the REC director at your specific facility for more information should you have any questions regarding your ongoing studies.
As always, animal welfare is our primary concern and we will all work together to ensure that appropriate care is delivered without interruption. Please contact the IACUC Office (firstname.lastname@example.org) or OLAC (email@example.com) for additional assistance.
All export-controlled research must be performed in accordance with pre-approved technology control plans. The requirements for physical security and cybersecurity associated with each project, as defined in the project-specific technology control plan and in accordance with federal regulations, are unaltered.
Deemed exports can occur when an individual from a particular disallowed (as defined by the sponsoring agency or the US government) country of origin gains access, information, or experience with restricted technology, materials, or equipment.
Also, deemed exports can occur through visual inspection without any direct contact with the restricted items. All export-controlled projects have a pre-approved personnel list defining who is allowed to work on the project. For situations where laboratory personnel are limited, this restriction must remain intact to prevent deemed exports. Alternate personnel must be reviewed and documented in accordance with the restrictions in the technology control plan before being allowed to work on the project. For any questions, please contact the export control officer Dairin Malkemus (firstname.lastname@example.org).