A component of the University of Michigan's Human Research Protection Program (HRPP) and a unit of the Office of Research, the six Institutional Review Boards of the University of Michigan Medical School (IRBMED) oversee human subjects research conducted at the Medical School and Michigan Medicine. Read more About IRBMED.
CORONAVIRUS (COVID-19) Updates and Guidance
IRBMED is committed to responding to matters associated with human participant research as the COVID-19 circumstances evolve. We encourage study teams to monitor the IRBMED website for any changes in workflows and for additional guidance.
IRBMED and its review functions are fully operational. IRBMED staff are working remotely.
STAY UP-TO-DATE! See IRBMED's Important Updates and Announcements Related to COVID-19 HERE
Study-Specific Planning Guidance: Guidance for new COVID-19 related projects and continuity planning for currently active studies.
Time Sensitive Research Modifications (Procedures for Urgent Amendments)
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.
- Time Sensitive Research Modifications During COVID-19 Workflow Chart
- 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): 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.
- 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.
New NIH Online Application System for Certificates of Confidentiality
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.
- 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
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.
email@example.com or 734-763-4768
eResearch Regulatory Management Upgraded on Mar 1, 2020
eResearch Regulatory Management (eRRM) system was upgraded on March 1, 2019. The eRRM system upgrade to 9.0 brings a number of user interface changes and navigation improvements to the smartforms for Human Subjects (HUM), Institutional Biosafety (IBCA), Participating Site (SITE), and Repository (REP) Applications.
These changes are detailed in this Overview of Changes.
Single IRB Mandate Compliance Date: January 20, 2020
Any multi-site research that is funded by a Federal Department or Agency that follows the Common Rule, will have to be approved under a single IRB model after January 20, 2020. For a full list of Departments and Agencies that follow the Common Rule, please follow this link and scroll down.
U-M IRBMED has agreed and will continue to agree to be the single IRB for research projects on a case by case basis. For more information on multi-site research, the single IRB mandates (including exceptions to the mandates), and how to request U-M IRBMED to be the single IRB, click here.
If you cannot find the answer you need on that website, please email: firstname.lastname@example.org
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.
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.
The 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.
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.
A 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 email@example.com.
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