Participant research visits (for UAB research conducted at both domestically and international locations) should be performed remotely (e.g., by phone,Zoom, or other means) whenever possible. It is critical that trial participants are kept informed of changes to the study and monitoring plans that could impact them.

For additional guidance on conducting in-person research visits, refer to the Resumption of Research in the Guide to Re-entry at this link: https://www.uab.edu/research/home/r2ops-human-subject-research-guidance

All study participants who are scheduled to be present on campus or any other UAB research facility for study-related interactions must follow the UAB Resumption of Research Operations Human Subjects screening protocol, which includes masking, and may include testing for participants or potential participants who screen positive for symptoms of COVID-19.

Please see the Resumption of Research Operations website for additional resources, and the most up-to-date guidance: https://www.uab.edu/research/home/r2ops-human-subject-research-guidance

Screening guidelines may change as circumstances of the pandemic evolve. Please refer to the Office of Research Business Continuity website for current guidelines on how to screen research participants for COVID-19: https://www.uab.edu/research/home/business-continuity-plan.

The UAB OIRB does not need to approve the incorporation of mandatory screenings, unless you or the sponsor wishes to incorporate the data collected as part of a new research objective of the clinical study. If so, the protocol will need to be amended and approved by the IRB.

The IRB recognizes that some deviations pose little to no threat to participant safety or scientific integrity. For example, when the subject misses a clinic visit and the only available re-schedule date is outside the study visit window, though no study procedures or medication doses are missed. In this case, the subject may not incur possible harm from a missed dose or missed procedures meant to maintain or evaluate the subject's safety and welfare.

As such, reporting is left to the discretion of the investigator within the context of the IRB’s reporting policy. Though a deviation may not pose a conceivable threat or possible harm, it may represent possible continuing non-compliance if an amendment is not pursued with the IRB. All deviations must be documented in the research record, regardless of whether they meet the IRB’s prompt reporting criteria.

Refer to the UAB Policy to Ensure Prompt Reporting of Unanticipated Problems Involving Risks to Subjects or Others to the IRB - IRB POL006 (https://www.uab.edu/policies/content/Pages/UAB-RA-POL-0000124.html) for information on problems that must be reported to the IRB promptly, versus those problems not meeting the UAB Criteria for "Reportable Problems" but are requested by the Sponsor to be reported to the IRB.  These events may be reported at the time of continuing review on the Problem Summary Sheet under Table B.

Modification requests are REQUIRED through submission of IRB Revision/Amendment Smart Form, and IRB approval must be obtained before you change study procedures (including consenting processes) for new or existing participants (e.g., transition to obtaining consent remotely, self-collection of data or biospecimens that would have been collected by researchers, etc.).

Example: You want to administer new and follow-up study questionnaires over the phone instead of in-person, or you want to do an in-home visit for assessment of surgical recovery instead of having participants come into the clinic.

It is recommended that any amendments transitioning study procedures to use remote study interactions be written with flexibility, so that the study can transition back to in-person study visits without necessitating a future amendment. For example, the consent form could indicate that procedures will be conducted remotely, if necessary.

There are some limited exceptions to the requirement for a modification: For IRB-approved applications that do not specify whether a procedure is remote versus in-person and the transition to remote visits does not otherwise change study procedures, you do not need to submit an amendment.

Contact Adam McClintock, Director of the Office of the IRB (amcclint@uab.edu) with any questions and copy irb@uab.edu).” Be sure to include the following information in your Modification:

• Potential impact on subject safety and protections
• Potential impact on scientific integrity and/or benefits of the study
• Plan for how existing subjects will be notified (if their participation will be affected by the modification)
• Number of existing participants affected by the proposed change (if any)
• Date of proposed change implementation
• Whether or not the proposed changes are permanent or temporary

There may be an urgency to deviate from the protocol or the conduct of research procedures before an amendment can be approved by the IRB. Some deviations will be minor. Some may have major effects on the welfare of participants and/or study validity.

All deviations must be reported according to the IRB’s reporting policy (POL006: https://www.uab.edu/policies/content/Pages/UAB-RA-POL-0000124.html).The IRB acknowledges that the COVID-19 outbreak and any resultant isolation/quarantine expectations may result in deviations that are intended to eliminate apparent immediate hazard to a research participant.

Some clinical studies involve in-person study visits in order to conduct safety monitoring of the participants. For example, participants in a drug treatment study may need to have regular examinations, interviews, or laboratory tests for specific possible side effects.

Researchers should follow all current Resumption of Research Operations guidance on in-person study visits. This may include a plan for alternatives to in-person monitoring visits, if possible. If appropriate for the study, this might include:

• Delay, postpone, or modify the visits
• Follow up via telephone or other form of remote communication
• Visits to participants’ for exams or specimen collection
• Use (or establishment) of a mobile specimen collection service

It is critical that trial participants are kept informed of changes to the study and monitoring plans that could impact them.

These modifications to safety monitoring procedures should be approved in advance by the IRB, except when necessary to eliminate apparent hazards to a participant and there is not sufficient time to obtain IRB approval. Consult with the UAB OIRB Compliance Manager, Lauren Tarpley McGibboney at ltmcg@uab.edu and copy the IRB Intake Staff at irb@uab.edu.

If you do need to change an approved monitoring procedure to eliminate immediate possible danger, please report it to the UAB IRB within 5 days, following the Reportable Problems procedures described at this UAB OIRB website (https://www.uab.edu/research/home/reporting-research-related-problems).

Remote monitoring visits and site initiation visits (SIVs) with Sponsors are preferred as a precautionary measure. In-person monitoring and site visits may occur when needed, but require that study personnel follow the same screening procedures described in this document for research participants for both remote prescreening within 24 hours ahead of the monitoring or site visit, and in-person screening on site prior to the monitoring or site visit initiation. For monitoring visits that span consecutive days, the study monitor must be screened in-person before proceeding with the monitoring visit each day.

Please see the Resumption of Research Operations website for additional resources, and the most up-to-date guidance: https://www.uab.edu/research/home/r2ops-human-subject-research-guidance

Submission of a Problem Report is NOT REQUIRED if you are halting, rescheduling, or delaying study enrollment.

Submission of a Problem Report is REQUIRED within 5 business days when you

• Have had to implement changes to study procedures (including halting, delay, or revision of monitoring procedures) to prevent an immediate apparent hazard to one or more participant and did not have time to obtain prior IRB approval, or
• Are halting, voluntarily suspending, re-scheduling or delaying procedures for current participants in studies with ALL of the following characteristics:
  • The study involves an Intervention (i.e., not observational or no contact), and
  • The study involves more than minimal risk to the participants (i.e., it was initially reviewed by the full convened IRB instead of minimal risk “expedited” review), and,
  • The suspension potentially has an impact on safety monitoring or the study’s scientific integrity
• Have study hold is initiated at the request of an external funding agency or the study’s Data and Safety Monitoring group (if there is one) due to the likelihood that study procedures pose an increased risk to participants who may contract COVID-19.

For research conducted by graduate students and postdoctoral fellows that is allowed to continue, it is expected that research mentors articulate a plan for these trainees and allow flexibility due to illness or other personal concerns. Any graduate students or postdoctoral fellows needing IRB consultations during this time may schedule a one-on-one, remote consultation by contacting Cari Oliver (croliver@uab.edu).

Please be aware that these guidelines will be updated as conditions change. We appreciate your patience during this time.

Some studies registered at the federal site ClinicalTrials.gov are modifying their research procedures to include testing for and/or assessment of COVID-19 symptoms. The ClinicalTrials.gov information for the study should be updated to include these new procedures, if they are done for research purposes.

The federal requirement about modifications is that any research-related changes must be added to the study’s ClinicalTrials.gov registration within 30 days after IRB approval of the modification.

Please refer to the ClinicalTrials.gov website for additional questions and guidance: https://prsinfo.clinicaltrials.gov/TopQuestionsFromResponsibleParties-Covid19.pdf or contact Denise McKenzie at dhmckenzie@uabmc.edu.

The Office of the IRB continues to prioritize protocols for vaccine trials and those offering access to investigational therapeutics.

If the submission is an initial submission for a vaccine candidate or investigational therapeutics, include the phrase, “COVID-19 RELATED SUBMISSION,” in the protocol title in IRAP and contact the OIRB as follows:

• Adam McClintock, Director of the Office of the IRB (amcclint@uab.edu)
• IRB Intake Staff (irb@uab.edu)

Some research projects may involve sensitive and protected data that have security controls mandated by the sponsor, policy, or federal law (examples: HIPAA, FERPA, Export-controlled, etc.). If your project is subject to a data security plan that precludes remote access, contact your Department, School/College, or UAB IT security administrator. Additional guidance on UAB Information Technology website about using the Box for restricted data and/or PHI: https://www.uab.edu/it/home/policies/data-classification/restricted-data.

Any human biospecimens that may be infected by SARS-CoV-2 must adhere to the requirements outlined in the document titled UAB COVID-19 Containment Guidance for Researchers: https://www.uab.edu/research/home/images/BCP/UAB_COVID-19_Containment_Guidance_for_Researchers.docx. Please refer to the Research Safety Committees Business Continuity FAQs for additional guidance: https://www.uab.edu/research/home/business-continuity-plan/research-safety-committees-faqs.

Studies that are eligible for a verbal consent (studies that do not involve more than minimal risk and do not involve procedures requiring consent outside the context of research) should request a waiver of consent documentation and authorization (if collecting PHI) by submitting the following forms at the time of initial review or amendment:

• FOR235: Waiver of Informed Consent Documentation
• FOR211: Waiver of Authorization

Studies that are not eligible for a verbal consent process should pursue one of the following methods for documenting consent and HIPAA research authorization:

• Use electronic form of obtaining signatures during the consent process (see FAQ #25).
• For participants who are unable to safely travel to campus to engage in a consent discussion due to restrictions related to COVID-19, researchers may use a process consistent with one of those outlined in FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic (specifically FAQ #11): https://www.fda.gov/media/136238/download. (December 4, 2020):
  • Methods that allow for an adequate exchange of information and documentation, and a method to ensure that the signer of the consent form is the person who plans to enroll as a subject in the clinical investigation or is the legally authorized representative of the subject.
    • For example, the consent form may be sent to the subject or the subject’s legally authorized representative by facsimile or e-mail, and the consent interview may then be conducted by telephone when the subject or subject’s legally authorized representative can read the consent form during the discussion.
    • After the consent discussion, the subject or the subject’s legally authorized representative can sign and date the consent form.
    • Options for returning the document to the clinical investigator may include:
      • Facsimile,
      • Scanning the consent form and returning it through a secure e-mail account,
      • Posting it to a secure internet address,
      • Mail it to the clinical investigator, or
      • Alternatively, the subject may bring the signed and dated consent form to his/her next visit to the clinical site, if restrictions on traveling to the clinical trial site are alleviated.
    • The case history for each subject must document that informed consent was obtained prior to participation in the trial.
    • In addition, the person signing the consent form must receive a copy of the consent form. Although FDA regulations do not require the subject’s copy to be a signed copy, FDA recommends that a copy of the signed consent form be provided.
    • If concerns exist about having subjects mail to the investigator potentially contaminated consent documents from the subject’s location, the investigator may employ the procedures described for enrolling patients in isolation through the use of a photographic image of the signed consent form transmitted through electronic means.
    • The subject or the subject’s legally authorized representative must sign and date the informed consent form before the investigator may conduct any study-related procedures involving the subject. Where it is not feasible for investigators to receive the signed consent form prior to beginning study-related procedures, the investigators should have the subject or legally authorized representative confirm verbally during the consent interview that the subject or legally authorized representative has signed and dated the form.
    • The overseeing IRB must review and approve the planned informed consent process.

Any change to the consent or HIPAA authorization process and/or documentation thereof must be reviewed and approved prior to implementation