A component of the University of Michigan's GENERAL SPOTLIGHT ANNOUNCEMENTS
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 their own 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.
IRBMED Seminar Series: A Comprehensive Look at Monitoring and Auditing of Human Participant Research
May 4, 2021
IRBMED held its Spring installment of its Seminar Series on May 4, 2021 which provided a comprehensive overview of monitoring and auditing of human participant research. Topics included identifying when a Data and Safety Monitoring Plan (DSMP) and/or a Data and Safety Monitoring Board (DSMB) is required and requirements for submitting DSMB reports, other monitoring reports and audit results to the IRB. A representative from the Office of Regulatory Affairs presented on FDA inspections as a form of audit and a representative from MICHR's Research Management team discussed monitoring requirements, available monitoring services, and monitoring examples.
The slides and a recording are available on the IRBMED Seminar Series page.
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)