GENERAL SPOTLIGHT ANNOUNCEMENTS
FDA-compliant version of SignNow Available
October 29, 2021
The university’s E-signature Service, SignNow, has a new version that is compliant with FDA regulations at 21 CFR Part 11. If you are someone who uses SignNow to obtain signatures for FDA-regulated documents, please fill out this form by November 29, 2021, and ITS will switch you over to the FDA-compliant version. You will receive a confirmation email once ITS has switched your account. After November 29, 2021, if you need your account to be the FDA‑compliant version, you should contact the ITS E-Signature team.
FDA-regulated studies still enrolling participants and using SignNow to document consent or assent electronically should transition to the FDA-compliant version of SignNow at the earliest opportunity but not later than December 20, 2021. Studies that are not FDA-regulated may use the standard version of SignNow to document consent or assent electronically.
More information is available here on the IRBMED website, including relevant FAQs.
IRBMED Seminar Series: Recording Available
October 19, 2021
Considerations for Research Involving Biobehavioral Elements and Mobile Health (mHealth) Technologies
IRBMED hosted its biannual Seminar Series on Tuesday, October 19, 2021, and a recording is now available. Registration to access the recording is required. through 11/18/2021 and registration is limited to University of Michigan users. Authentication requires the use of a U-M email address while logged into Zoom via a U-M account.
Seminar Summary: Projects involving health and biology data, including genetic and genomic data, with data on individual behaviors, environmental factors, and the use of mHealth technologies have their unique challenges. This seminar includes presentations on the ethical considerations involved in clinical research combined with biobehavioral elements.
Distinguished University of Michigan researchers Melvin McInnis, M.D. and Sachin Kheterpal, M.D., MBA, discuss their research. Nicole Eyrich, MPH, who works on projects that involve mHealth technologies as a clinical research project manager, describes considerations for the eResearch application. Beverly Yashar, a clinical professor of human genetics and IRBMED board member, presents the bioethical implications of genetic and genomic data collection. Katy Hunsche, an IRBMED senior associate regulatory analyst, addresses additional details for working with IRBMED on these types of projects.
Update to ORIO Submission Guidance for Studies Ceded to Another IRB
May 24, 2021
Recently IRBMED updated the guidelines for ORIO (Other Reportable Information or Occurrence) submissions for IRBMED studies ceded to another IRB. Now, ORIO submissions are only required to be submitted to IRBMED when the submission meets the reporting requirements for the external IRB (the IRB of record). For example, if the external IRB does not require a minor protocol deviation to be submitted, then IRBMED will not require a submission either. Please note that each external IRB can have its unique reporting requirements. So, when initiating a new study with an external IRB, it is good practice to understand the reporting requirements for that particular study. Also note that although the IRBMED ORIO reporting requirements have changed, the AE (Adverse Event) submission requirements have not changed. Serious, related, local adverse events still need to be submitted according to IRBMED Adverse Event Reporting guidance. See the links below for the specific reporting requirements.
HOW IRBMED SUPPORTS RESEARCH
Guidance documents represent the current thinking on the 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 per 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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