Institutional Review Boards (IRBMED)

IRBMED team in a conference room

IRBMED accreditation logoA 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.           

HUMAN RESEARCH DURING COVID-19 

During the COVID-19 pandemic, IRBMED is committed to responding to matters associated with human participant research as circumstances evolve. Study teams are encouraged to monitor this website for changes in workflows and for guidance. IRBMED and its review functions remain fully operational. IRBMED News, Updates and Announcements Related to COVID-19 are published here​​​

U-M Office of Research (UMOR): Research Guidelines During COVID-19

May 25, 2021

The requirement that studies submit a Human Research Activation Checklist has been suspended as of 5/25/2021. This suspension does not indicate the return to pre-COVID-19 research conditions. The safety of research participants, individuals accompanying them in their research participation, the research workforce, and our broader communities, is the leading priority. Study teams must adhere to all of the most up-to-date university policies as outlined on the UMOR Research Re-engagement website

For questions related to human research during COVID-19, please contact the U-M Human Research Reactivation Committee

Additional Information and Guidance for Human Research During COVID-19

 

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

 

 

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HOW IRBMED SUPPORTS RESEARCH

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All Guidance

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.

 

documentsInformed 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.


U-MIC logoEducation & U-MIC

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.

 

icon of paper labeled with S.O.P.Standard Operating 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.

 

crowd of people iconInformation 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.


Question mark iconFrequently Asked Questions

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 irbmed@umich.edu.

 

FREQUENTLY VIEWED DOCUMENTS

Standard Informed Consent Template

Exempt Human Subjects Research

Standard Operating Procedures

Adverse Event Reporting

Other Reportable Information or Occurrence (ORIO)

 

Questions?

Contact us at irbmed@umich.edu or 734-763-4768 / (Fax 734-763-1234)

2800 Plymouth Road, Building 520, Room 3214, Ann Arbor, MI 48109-2800

A list of IRBMED staff is available in the Personnel Directory, or view the list of Regulatory Teams.