TIERED HUMAN RESEARCH REACTIVATION DURING COVID-19
June 22, 2020
Beginning June 22, human research studies paused during the COVID-19 pandemic can apply for reactivation to the Human Research Activation Committees charged by the Office of the Vice President for Research. U-M research leadership has now developed protocols and procedures to safely re-engage in-person human research activity. The order and timing of these activation procedures considers proposed research benefits provided to individual participants balanced with the risk for COVID-19 community transmission. The process will utilize four Activation Tiers.
For more information, UMOR has issued guidelines and FAQs on the UMOR Research Re-Engagement Website and IRBMED has issued guidance for submitting Reactivation information, study changes as amendments or ORIOs to IRBMED.
Guidance on Preferred Methods for Obtaining Informed Consent for COVID-19 Research
April 17, 2020
IRBMED has new guidance detailing requirements for the preferred methods at Michigan Medicine for obtaining research informed consent from COVID-19 positive patients (or those undergoing testing) or their LAR. The appropriate option for an obtaining a patient’s consent will depend on the individual circumstances for the patient and require study teams to follow informed consent procedures as approved by the IRB. See the guidance and related documents below and contact IRBMED (firstname.lastname@example.org or 734-763-4768) with questions about these procedures.
Note: The ‘Wet Ink Signature / No Photo’ and ‘No Signature’ methods are not to be utilized outside of COVID-19 circumstances as they represent FDA guidance for obtaining consent during the pandemic.
- Informed Consent Coversheet: Information about Participating in a COVID-19 Research Study
- Study Team and Witness Attestation Form for SignNow Process in a COVID-19 Research Study
Informed Consent Language for Clinical Studies Researching COVID-19
April 16, 2020
On March 10, 2020, the Secretary of the Department of Health and Human Services (HHS) issued a declaration under the Public Readiness and Emergency Preparedness (PREP) Act for covered countermeasures against COVID-19. The declaration grants immunity to entities involved in COVID-19 countermeasures by limiting a research subject’s ability to sue if injury or harm occurs while participating in a COVID-19 clinical study (including Emergency Use studies). If participation in the study results in serious physical injury or death of a subject, the federal government has a program that may provide compensation to the subject or their family. IRBMED has issued new guidance related to this and required informed consent language for these COVID-19 clinical studies.
NIH Issues Automatic 12 Month Extension to Active Non-NIH Certificates of Confidentiality
April 15, 2020
Research studies that are funded by NIH are automatically deemed issued a Certificate under the NIH Policy on Certificates of Confidentiality (CoC). The CoC automatically extends as long as the NIH funding continues, including any no-cost extensions. Under normal circumstances institutions with CoCs for non-NIH funded studies are required to apply for a new CoC upon the expiration of the current one in order to extend the CoC protection past the stated expiration date. To decrease the burden for the research community, during the public health emergency for COVID-19, NIH is automatically extending the expiration dates for NIH issued CoCs that were current (i.e., not expired) as of April 15, 2020. NIH therefore deems all CoCs current (i.e., not expired) on April 15, 2020 for non-NIH funded studies to have a 12-month extension of their expiration date.
Please see additional details in the NIH notice here.
SignNow Software Now HIPAA and FDA 21 CFR Part 11 Compliant
April 9, 2020 10:45 AM
SignNow Software is now HIPAA and FDA 21 CFR Part 11 compliant for patient signatures. Study Coordinators are no longer required to have patients sign the HIPAA Permission to Use SignNow form before signing informed consent documents. See IRBMED updated guidance for Informed Consent Procedures Using Electronic Systems and Remote Use of Paper Documents and guidance for the use of SignNow for Electronic Informed Consent Procedures.
IRBMED Guidance for Electronic Informed Consent and other Remote Consent Procedures
Updated: April 9, 2020
Guidance is available for research studies that require signed informed consent but require a remote procedure for the consent process. Electronic and remote informed consent procedures are permitted by IRBMED and must meet the same regulatory and institutional requirements of an in-person paper-based informed consent process. Guidance is available on Research A-Z here.
OHRP Issues Guidance on COVID-19
April 8, 2020
The federal Office for Human Research Protections (OHRP) issued guidance for institutional review boards (IRBs) and the research community on the coronavirus (COVID-19) pandemic. The guidance provides information about the following topics:
- Public health activities and clinical activities;
- Excluded public health activities;
- Legally required reporting;
- Requirements when eliminating apparent immediate hazards to participants;
- Proposing and reviewing study changes; and
- Whether suspensions must be reported to OHRP.
The guidance indicates that previously issued U.S. Food and Drug Administration (FDA) guidance on clinical trials during the COVID-19 pandemic is consistent with the regulations at 45 CFR 46, even if the research is not also regulated by the FDA. Additionally, it states that 2018 OHRP guidance, “Effects of Disasters on Human Research Protections Programs,” may be applicable during the COVID-19 pandemic.
COVID-19 Research Prioritization Committee
March 23, 2020
The U-M Office of the Vice President for Research (UMOR) has organized a Research Prioritization Committee to review and prioritize new or modified research projects related to the study of COVID-19. For more information about the committee, and to access the intake form, go to the UMOR page (https://research.umich.edu/covid-19) and scroll to the left paragraph at the bottom of the page. Submit the committee’s approval/authorization in Section 44 of the IRB application. If you have questions, please email email@example.com
FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic
On March 18, 2020, the U.S. Food and Drug Administration issued guidance for institutional review boards (IRBs), industry, and investigators conducting clinical trials during the coronavirus (COVID-19) pandemic. On March 27, 2020, FDA amended the guidance to include an appendix to further explain those general considerations by providing answers to questions about conducting clinical trials that the Agency has received during the COVID-19 pandemic.
Of note regarding documentation for missed protocol-specified 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 study visits or study discontinuations due to COVID-19).
IRBMED COVID-19 Related Guidance for Researchers
Informed Consent Procedures Using Electronic Systems and Remote Use of Paper Documents (updated April 9, 2020)
Use of SignNow for Electronic Informed Consent Procedures (April 9, 2020)
Study-Specific Planning Guidance: Guidance for new COVID-19 related projects and continuity planning for currently active studies (April 29, 2020)
IRBMED guidance detailing when and how to submit urgent modifications to either eliminate an apparent immediate hazard to subjects (rare), OR submit time-sensitive modifications in response to COVID-19 when subject safety is not a concern. When subject safety is not a concern a standard amendment should be submitted unless one is in progress. When an amendment is progress, some urgent modifications are eligible for approval through an ORIO submission in eResearch. See below.
- Time Sensitive Research Modifications During COVID-19 Workflow Chart (March 25, 2020)
- Research Studies Ceded to an External IRB (March 25, 2020)
- Submit study-specific questions to the IRBMED staff owner identified for the study in eResearch.
- Submit any general questions to firstname.lastname@example.org. This email will be monitored during normal business hours and over the weekend. Responses will be provided within one business day.
Other Important U-M Resources: COVID-19 Related Research Operations
- U-M Office of Research (UMOR) COVID-19 Research Solutions
- COVID-19 Research FAQs Page, Information, updates and answers to common questions regarding research and other scholarship activities.
- U-M Medical School Office of Research: Updates from units within the Office of Research regarding their services and operations.
- New restriction in human subject research due to COVID-19: March 13, 2020, email from Interim Vice President for Research Rebecca Cunningham, MD, to the research community.