A component of the University of Michigan's COVID-19 Guidance Related to IRBMED Submissions
Human Research Reactivation - Guidance for Submitting Information to IRBMED
Reporting Time Sensitive Modifications
KEY POINTS FOR SUBMITTING REACTIVATION INFORMATION, STUDY CHANGES AND ORIOS TO IRBMED
Submitting Study Changes to IRBMED
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There is no need to submit an Amendment or ORIO for research reactivation purposes unless changes to the IRB application or supporting materials (e.g., informed consent, protocol, drug or device administration, recruitment procedures) are needed.
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If the intended changes are time-sensitive, please follow the IRBMED guidance for reporting the Time-Sensitive Modifications. Note that this guidance has been updated for Reactivation purposes.
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Label the submission appropriately so that these submissions can easily be identified. Labeling instructions are provided in the Reporting Time-Sensitive Modifications guidance.
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Study teams can submit the research Reactivation Request (Qualtrics link available on the UMOR website) and Amendments to their IRB application at the same time. However, research should not be reactivated until both IRBMED and Reactivation Committee approvals are obtained.
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Protocol deviations not previously submitted to IRBMED should be reported according to the standard IRBMED ORIO Reporting Guidance.
Reporting the Reactivation Committee Approval to IRBMED
- Once the study team obtains the approval from the Reactivation Committee, submit this notification to IRBMED via the Post Correspondence activity (in eResearch main study workspace) by selecting “IRBMED” as a recipient. This activity allows for uploading of documents. Notification of the Reactivation approval should not be uploaded into the IRB application itself.
- Once the correspondence is posted, IRBMED will manage this notification internally.
- Do not submit an ORIO or Amendment to only report the Reactivation Committee's approval.
Questions on Activation procedures should be directed to human-research-activation@umich.edu
General questions regarding the IRBMED applications should be sent the IRB staff owner of the submission (this information is available in eResearch) or via IRBMED general email address irbmed@umich.edu.
Reporting Time-Sensitive Modifications
IRBMED is currently adequately resourced to address the time-sensitive submissions promptly. Once a submission is a received by IRBMED, it will be screened and assigned to the appropriate IRBMED staff within 24 hours during the normal business hours. Submission volumes are closely monitored by IRBMED so additional resources (weekend coverage, additional board meetings, eResearch tools, etc.) can triggered as needed.
Guidance for Reporting Time-Sensitive Modifications (June 2020) is available here.
COVID-19 Guidance Related to Informed Consent Procedures
- Research Informed Consent Procedures for COVID-19 Positive Patients (April 17)
- Informed Consent Coversheet, Information about Participating in a COVID-19 Research Study (April 17)
- Study Team and Witness Attestation Form, for SignNow Process in a COVID-19 Research Study (April 17)
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. Contact IRBMED (irbmed@umich.edu) or 734-763-4768) with questions about these procedures.
- PREP ACT Language for COVID-19 Research Informed Consent (April 16)
- Informed Consent Procedures Using Electronic Systems & Remote Use of Paper Documents (Updated April 9)
- SignNow for Electronic Informed Consent Procedures (April 9)
- U-M SignNow, E-Signature Service available for use by U-M staff, faculty, researchers and students.
- U-MIC: Electronic Informed Consent Using SignNow
IRBMED COVID-19 FAQs Related to Research Reactivation
IRBMED COVID-19 FAQs Related to Research Reactivation
A list of FAQs is available to answer commonly asked questions related to IRBMED submissions and research reactivation. If you cannot find an answer to your question here, contact the IRB staff owner of the submission (this information is available in eResearch) or send your question to irbmed@umich.edu.
Also see the UMOR COVID-19 Research Re-engagement website for FAQs on Human Research Re-engagement and re-engagement guidelines.
Single IRB and Multi-Site Research Information for Research Reactivation
Ceded studies
Studies that are utilizing an external IRB must still follow all UMOR procedures for ramping up the study. This includes obtaining approval from the Reactivation Committee. An amendment (or ORIO) must also be submitted to IRBMED prior to re-opening the study.
sIRB Instructions
Please check back to this page frequently for specific instructions and guidance regarding ramping up sIRB studies.
All UM study teams will need to collect current information from each participating site regarding current, local study status. If UM is the IRB of Record, as the lead study team, download this Single IRB COVID-19 Checkpoint Survey for Participating Sites and fill out the study title and HUM#. After that is done, send this document to all of the participating sites that UM IRBMED is the IRB of record for. Each site will need to fill out the survey and return it as directed at the bottom of the survey.
COVID-19 Guidance From Federal Agencies (OHRP, FDA, and NIH)
- FDA Guidance on Conduct of Clinical Trials of Medical Products During COVID-19 Public Health Emergency, Guidance for Industry, Investigators, and Institutional Review Boards (Updated April 16)
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).
- NIH Issues Automatic 12 Month Extension to Active Non- NIH Certificates of Confidentiality, 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.
(April 15)
- OHRP Issues Guidance on COVID-19, Office for Human Research Protections (OHRP) issued guidance for institutional review boards (IRBs) and the research community on the coronavirus (COVID-19) pandemic. (April 8)
Other COVID-19 Related Guidance for IRBMED eResearch Submissions
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Study-Specific Planning Guidance: Guidance for new COVID-19 related projects and continuity planning for other currently active studies.
Note: 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. (April 29)
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Submit study-specific questions to the IRBMED staff owner identified for the study in eResearch.
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Submit any general questions to irbmed@umich.edu. This email will be monitored during normal business hours and over the weekend, when needed. Responses will be provided within one business day.
Important University of Michigan Research Operations Information Related to COVID-19
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June 19 Re-Engagement Communication from U-M Vice President for Research, Rebecca Cunningham
- U-M Office of Research (UMOR) COVID-19 Research Solutions
- COVID-19 Research FAQs Page, Information 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.
- March 14 Restriction in Human Subject Research due to COVID-19, Communication from U-M Vice President for Research, Rebecca Cunningham
IRBMED News, Updates and Announcements Related to COVID-19 are published here.
GENERAL SPOTLIGHT ANNOUNCEMENTS
SignNow Software HIPAA and FDA 21 CFR Part 11 Compliant
April 9, 2020
SignNow Software is 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.
New NIH Online Application System for Certificates of Confidentiality
March 3, 2020
Certificates of Confidentiality (CoCs) protect the privacy of research subjects by prohibiting disclosure of identifiable, sensitive research information to anyone not connected to the research except when the subject consents or in a few other specific situations.
NIH has updated its Certificate of Confidentiality request process for non-NIH funded research through a new CoC online system. The current Certificate of Confidentiality system is being retired in March 2020. NIH will be unable to accept new CoC requests from March 11 to March 19, 2020, while NIH transitions to the new CoC system. The new system streamlines and simplifies the CoC request process by using self-certification statements and shortened text fields, as opposed to attachments. The new system also requires direct submission by the authorized institutional official rather than the investigator. NIH will update its CoC webpage to provide additional information about these upcoming changes.
Please note that this update does not apply to NIH funded research. NIH provides Certificates automatically for all NIH-funded and conducted research studies that began on or after December 13, 2016 fall per the NIH Policy for Issuing Certificates of Confidentiality.
Key Points:
- As of March 11, 2020, NIH will no longer accept CoC requests through the current Certificate of Confidentiality system.
- NIH will be unable to accept new CoC requests from March 11 to March 19, 2020, while NIH transitions to the new CoC system.
- As of March 13, 2020, access to the current system will no longer be available. Current users who wish to obtain copies of their CoC documentation should access the system prior to that date.
Additional information is available at the NIH Certificates of Confidentiality website: https://humansubjects.nih.gov/coc/index.
Planned Administrative Withdrawal of Applications by IRBMED
March 4, 2020
An IRB application is considered “abandoned” by IRBMED when the application has been with the study team for more than 6 months without the study team addressing the changes required for approval. This applies to new study applications (HUMs) as well as child submissions (AME, SCRs, and ADVs). Addressing these large volumes of “abandoned” studies that do not have an appropriate state of closure is important as we start planning toward transition to the new eResearch application in the coming years.
This announcement describes IRBMED’s action plan to manage these abandoned IRB applications, beginning on March 2, 2020.
- New study applications or Amendments that have been pending since 2018 or earlier years, will be withdrawn in the eResearch system through the “Administrative Withdrawal” activity without prior individual notice to study teams. After this action is completed, study team members will be notified of the action through an automated correspondence in eResearch. After an application is withdrawn, it is archived and no longer able to be submitted; however, study teams will be able to access information from the IRB application at any time.
- For new study applications or Amendments pending from January 2019 to September 2019, the study team will be contacted in eResearch for a status update. If there is no response from the study team by the timeframe specified in the correspondence, these applications will also be administratively withdrawn by IRBMED. After an application is withdrawn, it is archived and no longer able to be submitted; however, study teams will be able to access information from the IRB application at any time.
- For Continuing Reviews or ADV (AE/ORIO) submissions, irrespective of the timeframe, the study team will be contacted in eResearch for a status update.
Contact IRBMED with any questions or concerns.
irbmed@umich.edu or 734-763-4768
HOW IRBMED SUPPORTS RESEARCH
Guidance documents represent the current thinking on protection of human subjects in research. You can search and bookmark any guidance document in Research A-Z.
Informed Consent & Assent Templates
IRBMED offers numerous downloadable templates to assist researchers in creating informed consent and assent documents. In addition to standard consent and assent templates, several specialty templates, for use in specific types of research situations, are also offered. You can search and bookmark any template in Research A-Z.
Education & U-MICThe goal of IRBMED’s Education Program is to meet the ongoing educational needs of the research community. In addition to in-person classroom education on an assortment of relevant topics, IRBMED also offers multimedia presentations (U-MIC), which are short videos and voiceover slide shows that address topics relating both to ethics in human subjects research and to IRB procedures.
The IRBMED Standard Operating Procedures serve as the method by which the IRBMED implements the governing rules of the HRPP Operations Manual (OM). The IRBMED Standard Operating Procedures serve as a reference for investigators, IRBs, administrators, and others.
Information for Study Subjects
The IRBMED protects the rights and welfare of participants in clinical trials and other human subjects research studies by careful review and monitoring of research in accordance with applicable laws, regulations, and University policies.
Frequently Asked QuestionsA list of FAQs is available to answer commonly asked questions by the research community. If you cannot find an answer to your question here, please contact us at irbmed@umich.edu.
FREQUENTLY VIEWED DOCUMENTS
Standard Informed Consent Template
Exempt Human Subjects Research
Other Reportable Information or Occurrence (ORIO)