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HRPP Guidance During COVID-19

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 utk-imedris@listserv.uthsc.edu is included in your safe senders list.

RESEARCH OPERATIONS

Find comprehensive information on UT’s research perations during COVID-19 on the Office of Research & Engagement website

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 (utkirb@utk.edu), phone message (865-974-7697), or by contacting an HRPP staff member directly. All phone messages and emails will be answered as soon as possible.

The HRPP has designated that all research activities involving in-person contact with participants may resume after submission and approval of COVID-19  protective procedural documents as described below. The process of requesting exceptions to resume in-person research has expanded. Procedures that do not require in-person contact with participants that have been approved by IRB can continue. If appropriate to the research, investigators may submit protocol changes to the IRB that change procedures to those that do not require in-person contact. Investigators may also submit new protocols for review that include in-person contact to be ready to immediately start research when in-person contact is allowed by HRPP.

In-Person Contact with Research Participants

Requesting to Resume In-Person Research During COVID-19

The HRPP strongly encourages any human subjects research that can be performed without in-person contact to continue in that manner. However, the HRPP is removing the previous restrictions on in-person research. Please note that this is subject to change based on public health and safety considerations on campus and the larger community. Researchers may submit a Request to Resume In-Person Research During COVID-19. Please see the following documents for guidance on what should be submitted to make this request. The HRPP will review all requests submitted and make determinations on a case-by-case basis to ensure that the safety of both researchers and research participants are protected in accordance with campus and other site requirements. The purpose of the submission is two-fold: to ensure the adequacy of the protective process and to allow the HRPP to better assist and inform our research community in the event that COVID-19 restrictions are reinstated.

IRB Requests

All new applications and amendment requests will be prioritized as follows:

Initial Reviews

  • COVID-19 studies
  • Application with funding approval needs

Amendment Requests

  • COVID-19 related changes
  • Safety-related changes
  • Funding changes

New Studies

Submitting New Studies

New applications are still being accepted and reviewed. New studies are being 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 begin after submission and approval of request to resume documents 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 unless a formal exception has been granted by the HRPP

Rapid Response Grants

The IRB is currently prioritizing reviews for COVID-19 related studies and applications with funding approval needs.

Ongoing Studies

Funded Research

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.

ClinicalTrials.gov

The current ClinicalTrials.gov guidance on updating a registered study tells 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.

Requests to Resume In-Person Research

If researchers wish to resume in-person research interactions they may submit a request to the HRPP with documentation that details the additional protections in place to deter COVID-19 exposures. The restrictions on in-person interactions must be followed for those studies seeking an appeal until an appeal is granted.

Amendment Requests

If researchers wish to make changes to their research to limit in-person research activity (such as changing in-person data collection to remote data collection) an Amendment Request must be submitted to the IRB. 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 in their amendment request submission.

  1. Address if the changes are temporary or permanent.
    1. Temporary means remote interactions will be used until in-person interactions can resume.
    2. Permanent changes mean that remote procedures will replace in-person interactions until the study is completed and closed with the IRB.
  2. Consider if changes include recruitment, participant screening, the informed consent process, interventions, data collection methods, follow-ups, etc.
  3. When making temporary changes to your study:
    1. 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.).
    2. Do not include specific dates. Instead, state that regular in-person study activities will resume once the UT HRPP/IRB announces that it is safe to do so. This will avoid having to submit follow-up amendments or reports should currently predicted end dates be changed.
    3. 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.
  4. 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.
    1. (925) Study Synopsis – Possible changes to eligibility screening (if after the informed consent procedure for the study), methods for interventions, and data collection.
    2. (1600) Participant Recruitment – Possible changes to how participants are identified, contacted (i.e., informed about the research opportunity), or screened for study eligibility (if prior to the informed consent procedure for the study).
    3. (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.
    4. (2800) Privacy and Confidentiality – Possible changes such as using an online survey tool, moving data storage from hard drive to cloud account, etc.
    5. (3050) Describe Payment – Possible changes in types of compensation and how compensation is provided to participants.
    6. (3329) Informed Consent – Possible changes include a request to waive the requirement to obtain the participant’s signature (online data collection, interviews, etc.).
    7. (3440) Consent Process – Possible changes include obtaining a participant’s signed informed through secured electronic mechanism in place of in-person consent procedures.
  5. Revised or added study materials such as recruitment material, screening scripts or forms, consent forms, intervention materials, data collection instruments, etc.
  6. 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.
    1. (800) UTK General Study/Project Information, Item 1.3
    2. Check Other Application Changes to address changes in any procedures used.
    3. If revising an existing consent form, select Revise Currently Approved (English/non-English) Consent Form as applicable to the study.
    4. If revising existing recruitment material, data collection materials, etc., select Other.
    5. (810) Revisions of the Study/Project Application, Item 2.1, Rationale for Revision column – List Coronavirus. This will help flag these submissions for review.
    6. (400) Revisions to English Consent Form(s) – Select yes if applicable to your study.
    7. (600) Revisions to Non-English Consent Form(s) – Select yes if applicable to your study.
    8. (900) Other Changes

Communicating the postponement of research activities to participants does not require IRB review or approval.

Remote Activities

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.

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 before generating, relocating, accessing, or storing the data. There are several UT resources available to enable researchers to work remotely.

Security Concerns

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 locations (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 applications, describe all security safeguards.

External IRB

The additional requirements for 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 COVID-19 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 a COVID-19 screening procedure when conducted solely to determine whether the study visit should take place, be rescheduled, or canceled and when the screening information is not being kept for research purposes

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 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.

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 unless an exception is granted to allow in-person interactions.

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 the 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 applies 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.

Obtaining Consent

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 the 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

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 allowed 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.

Implied Consent

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 checkmark 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 place 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 signatures that provides an encrypted identifiable “signature.”  For example, DocuSign or another system that authenticates the user.

Consent Process

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.