IRB and Human Subject Research
In keeping with the Chancellor’s message on August 2 regarding safety measures for the COVID-19 delta variant, the HRPP requests that all human subjects researchers and participants employ mask wearing and social distancing. These preventive measures should be reinstated based upon the expectations of our local area and are applicable to all faculty, staff, students, and visitors. For researchers whose activities occur off-campus, please continue to follow any additional requirements that may be in place at those sites.
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 will begin transitioning back to a balance of in-office and remote availability beginning June 1. 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 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. 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 immediately commence upon full IRB approval.
In-Person Contact with Research Participants
The HRPP is removing the previous restrictions on in-person research, beginning June 1, 2021. New studies are being screened and routed for IRB review in accordance with our current procedures and timelines. Please note that this is subject to change based on public health and safety considerations on campus and the larger community. The materials provided below are in support of human subjects and researcher protections and may be used at the discretion of the research team. No additional approvals are required to use these materials.
- COVID-19 Information for Research Participants: Digital | Print
- Research Participants Screening Questions
- Contact Tracing Form for Research Participants
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. 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 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.
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.
- 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.).
- 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 study 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. should be submitted with the Amendment Request.
- 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.
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.
- HRPP Tip Sheet: Resources for Secure, Remote Human Subjects Research
- 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 before 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 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.
Guidance related to impacted 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.