IRBMED Guidance: Human Research Reactivation

 

TIERED HUMAN RESEARCH REACTIVATION DURING COVID-19               

Updated 12/14/2020

Human research studies paused early in the COVID-19 pandemic were eligible to apply for reactivation through the Human Research Activation Committees charged by the Office of the Vice President for Research beginning late July 2020. In November 2020, Tier 2 human research studies classified as an observational study or Benefit Level 4 on the human research activation checklist were required to pause in-person activity with research participants. 

 

                         Key Points to Submitting Human Research Reactivation Information to IRBMED

 

Submitting Study Changes 
 

Reporting Reactivation Committee Approval 
 

  • ​Label submissions appropriately and provide adequate details. See guidance below for labeling instructions and adequate details. 

     

  • Submit notice of approval from the Reactivation Committee, to IRBMED via the Post Correspondence activity (in eResearch main study workspace) by selecting “IRBMED” as a recipient and upload the document. 
     

  • Research Reactivation Requests and Amendments to the IRB application can be submitted at the same time. Both are required for reactivation.

  • Notification of the Reactivation approval should not be uploaded into the IRB application itself. 

     

  • New research applications should be submitted to IRBMED first and submitted to the Research Activation Committee after IRBMED approval.

  • ​Do not submit an ORIO or Amendment to only report the Reactivation Committee's approval. 

     

  • Protocol deviations not previously submitted to IRBMED should be reported according to the standard IRBMED ORIO Reporting Guidance.

 

 

 

 

Reporting Time-Sensitive Modifications

12/21/2020

See IRBMED guidance: Reporting Time-Sensitive Modifications

 

Study-Specific Planning for Research Reactivation

PDF Version

07/10/2020
 

PROCEDURES FOR BEGINNING OPERATIONS DURING RESEARCH REACTIVATION:

The UMOR website (https://research.umich.edu/covid-19) provides specific details associated with research reactivation (Tier) procedures. To assure the safety of research participants, individuals accompanying them in their research participation, the research workforce, and the broader communities, research is being reactivated in four Tiers. Benefits of the research to individual participants is balanced with the risk of COVID-19 community transmission.

The following information is provided to assist the study teams in preparing their activation plans in compliance with applicable regulations, UMOR and IRBMED procedures, and best practices.

 

1. Contact study sponsors prior to reactivation

Contact federal, industry, or private sponsors and/or any coordinating center for any study-specific information and guidance. Ensure that guidance provided is consistent with U-M policies and guidelines. Study teams may require information and guidance on specific issues including:

  • Changes in reporting requirements and documentation of deviations due to COVID-19

    • Alternative safety assessments due to delays

    • Delayed or missed participant contacts/visits

  • How delayed or missed participant contacts/visits may impact on-going study participation (e.g. whether a missed safety assessment might impact the ability of the participant to receive the next round of therapy)

  • Any changes to biospecimen/sample storage and shipping requirements

  • Drug shortages or delays in shipping and the subsequent impact on study conduct

  • Changes to the study procedures requiring IRBMED approval ​

2. Develop study-specific plans

The type of research being conducted will determine what revisions are required to the research plan. If the research has a sponsor, formal instructions may have been provided which will simplify the study team’s need to consider all subject facing aspects of the research. If not, develop a plan for implementation which takes into account the UMOR assigned Activation Tier as well as U-M policies and guidelines.

IRB amendments will be necessary if protocol changes were not previously approved to take into account alternative procedures involving the following categories of changes. Note, however, that not all studies will require all of these type of changes.

  • Sponsor provided information and protocol changes (from prior section)

  • Remote procedures that substitute for on-site visits, such as home visits, video research visits, and remote consenting

  • U-M Research Pharmacy operations as applicable 

  • Ability to conduct research interventions in current locations

  • Orderly withdrawal of subjects if indicated or necessary

  • Substantive delays in the ability of the team or participant to complete study procedures

  • Other treatment options for patients not able to access clinical trials (e.g., cancer, cardiac patients)

  • Schedule of planned communication with sponsors

  • Revised plans for community recruitment of participants (in the event the study remains open for recruitment)

  • Contact ORSP for cost/charge/effort considerations on sponsored projects

3. Prepare Plans to address resource availability and communication

  • Facility availability

  • Study team and clinical staff availability

  • Emergency communication plans within the study team

  • Communication with participants (i.e., participants are kept informed of research reactivation and expectations)

  • Compliance with UMOR social distancing and other unit or workplace limitations

4. Prepare and submit necessary IRB applications via eResearch

Prepare necessary amendments, continuing reviews, Adverse Event and ORIO reports to IRBMED. Follow the tips below and watch the IRBMED website for updates on any workflow adjustments.

Per FDA guidance, “COVID-19 screening procedures that may be mandated by the health care system in which a clinical trial is being conducted do not need to be reported as an amendment to the protocol [emphasis added] even if done during clinical study visits unless the sponsor is incorporating the data collected as part of a new research objective.”

IRBMED strongly recommends that study teams follow this FDA guidance when submitting Amendments in eResearch. Generally, an Amendment is NOT required for the mitigation procedures that are required by the University of Michigan (like hand hygiene, masks, temperature checks, screening questions, etc.) unless the study team is planning to incorporate the data collected as part of a new research objective. However, an Amendment is required for the study-specific mitigation procedures (such as remote consent or remote study procedures) that are not previously approved by IRBMED.

  • New Study applications:
  • New study IRB applications (or, other submissions) can continue to be submitted for IRBMED review. However, along with the previously-approved research, these applications must be conducted in compliance with applicable U-M COVID-19 policies and guidelines.

  • Studies should be submitted to IRBMED first for review and approval, then study teams should complete the Activation Checklist.  

  • Both approvals (IRBMED and Human Research Activation Committee) are necessary before beginning the study.

  • See IRBMED guidance for initiating new COVID-19 related research.

  • Time-Sensitive Modifications:
  • Carefully assess whether it is a study-wide change that should be submitted as an  Amendment (preferred) or a time-sensitive, one-time or temporary change that may be submitted as an ORIO. See IRBMED guidance: Reporting Time-Sensitive Modifications

  • Label the submission appropriately (Time-Sensitive, Urgent, Activation, etc.) by editing the title when creating the submission in eR.

  • Include adequate details in the submission to minimize the need for additional queries from IRBMED.  Instead of indicating ‘everything is remote’, provide additional details, as applicable. For example:

  1. Clearly indicate the study procedures that will be done remotely

  2. Indicate how many subjects will be impacted by the change (one or all)

  3. Describe the impact of the changes on the previously enrolled subjects or to-be-enrolled subjects

  4. Indicate how the impacted subjects be notified of changes (e.g., email or phone calls or letters or at their next visits). Provide scripts where applicable.

  5. Indicate specific remote or electronic medium (Zoom, SignNow, REDCap, etc.) that will be used by the study team

  6. Include the stage, phase, or cohort interaction currently taking place in the research. How many current subjects will be affected by the revisions, or if subjects are in different stages of research interaction (some in active research interaction/intervention, some only being followed for follow up surveys)

  7. Use the categories described in section 2 of this guidance and the examples above as an outline for the study specific changes. Summarize the proposed changes in the Amendment Coversheet and use the summary to check that each change is reflected in the amendment application section and in any related support documents (the protocol, informed consent, and recruitment material.

  • Upload any necessary documentation in appropriate sections to trigger appropriate reviews.

     For example:

  1. Section 15 (Drugs) uploads trigger Research Pharmacy review

  2. Section 10-1 (Informed Consent) uploads may trigger CRAO (Billing calendar) review

  • Electronic Informed Consent/Signature and Informed Consent with Documentation Waiver should be identified appropriately in the IRB application:
  1. Example of Documentation Waiver: As part of a Qualtrics survey, the study team will provide the necessary information and ask the subjects to click a link if the subject is agreeing to participate. Completing and submitting the survey questions indicates informed consent. For this method, request for documentation waiver must be completed in Section 10-4 (by selecting the appropriate option in Section 10.1).

  2. Example of Electronic Consent: Subjects will be required to provide their signature electronically via SignNow after reviewing the information about the study. For this, a documentation waiver is not applicable.

  • Submitting Protocol Deviations:
  • Review IRBMED ORIO Reporting Guidance and clearly identify whether the deviation is major and should be reported via ORIO within 7 days or minor to be reported at the time of SCR.

  • For protocol deviations, especially related to COVID-19 procedures, the FDA urges investigators to capture specific information in the case report form that explains the basis of missing data, including the relationship to COVID-19 for missing protocol-specified information (e.g., from missed/delayed study visits or study discontinuations due to COVID-19).

EMERGENCY USE OF A TEST ARTICLE

Procedures to request emergency use of an investigational test article will remain the same. For additional information, refer to https://az.research.umich.edu/medschool/guidance/emergency-use-test-article-life-threatening-circumstances

 

Questions?

Contact us at irbmed@umich.edu or 734-763-4768 / (Fax 734-763-1234)

2800 Plymouth Road, Building 520, Room 3214, Ann Arbor, MI 48109-2800

A list of IRBMED staff is available in the Personnel Directory, or view the list of Regulatory Teams.