IRBMED Guidance COVID-19: Study-Specific Planning

IRB Study GuidanceUpdated April 29, 2020

Initiating New Human Subject Research Related to COVID-19

IRBMED is receiving questions from the researchers about the possibility of testing for SARS-CoV-2 and/or assessment of COVID-19 symptoms as part of a research study. If you are planning to initiate or amend a research protocol to study the novel coronavirus COVID-19, contact IRBMED at your earliest opportunity (irbmed@umich.edu) before creating or amending the IRB application in eResearch. This will allow us to better assist you with appropriate IRB review as well as compliance of federal/state regulations and institutional policies. When submitting an email with COVID-19 related questions, note this in the subject line of your email so that we can prioritize these requests appropriately.

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-arti...

Study Team Procedures for Continuity of Operations:

In an effort to minimize the risk of contracting or spreading COVID-19 in human participant research interactions and to preserve personal protective equipment (PPE) for clinical care, the university is placing temporary restrictions on human subjects research effective Saturday, March 14 and continuing through May 1. The university will continue to re-evaluate this timeframe and make changes, as needed.

Full details on U-M research restrictions can be found here: UMOR COVID-19: Research Operations at U-M

 

The following procedures should be followed for continuity of operations:

1) Contact study sponsors (e.g., federal, industry, private) and/or the coordinating center for study-specific information and guidance. Please ensure that any guidance provided is consistent with the temporary research restrictions. Study teams may require information and guidance on specific issues including:

  • Changes in reporting requirements
  • Any changes to biospecimen/sample storage and shipping requirements
  • Drug shortages or delays in shipping and the subsequent impact on study conduct
  • Alternative safety assessments due to delays
  • Delayed or missed participant contacts/visits
  • How delayed or missed participant contacts/visits for participants 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)
  • Changing to the study procedures with appropriate IRB approval ​

2) Develop study-specific plans for each active study considering the U-M research pause and restrictions and also take into account the following:

  • Sponsor provided information (from prior section)
  • Need for continuity of the research intervention during the study period based on the requirements of the U-M pause
  • Make every effort to change from on-site visits to home visits or telemedicine (or telephone visits)
  • Level of U-M Research Pharmacy operations as applicable 
  • Facility availability
  • Study team and clinical staff availability
  • Ability to conduct research interventions in current locations per U-M restrictions and Michigan Medicine policies
  • 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)
  • Maintaining communication with sponsors
  • Restrictions or accommodations associated with community recruitment of participants (in the event the study remains open for recruitment)
  • Contact ORSP for cost/charge/effort considerations on sponsored projects

3) Study team planning

  • Identify emergency contacts within the study team
  • Develop a communication plan with the study team and participants (i.e., assure participants are kept informed if clinic visits or administration of study intervention is canceled or delayed)
  • Prioritize work
    • New study IRB applications (or, other submissions) that are not related to COVID-19 can continue to be submitted to IRBMED for review.  Approved research must be conducted under the parameters of the UMOR research restrictions.

4) Continue to prepare and submit necessary IRB applications via eResearch including amendments, continuing reviews, AEs, and ORIOs to IRBMED (watch the IRBMED website for updates on any workflow adjustments).

IRBMED eResearch Submissions

Refer to IRBMED Guidance COVID-19: Submissions to IRBMED

 

 

 

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.