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.           

For guidance and considerations on research activities during COVID-19, see:
IRBMED: Human Research During COVID-19.

 

GENERAL SPOTLIGHT ANNOUNCEMENTS

IRBMED Appoints New Assistant Director 

April 26, 2022

IRBMED is pleased to announce that Purna Garimella, MS, CIP, RAC, has accepted the role of Assistant Director, effective April 18, 2022. In this role, he will be primarily responsible for all regulatory staff who perform regulatory reviews within the IRBMED Office. This includes the full board regulatory staff and the expedited regulatory staff. Purna Garimella has been with the IRBMED office since April 2011 in various roles and most recently served in the expedited team lead role. Purna holds a Master of Science (M.S.) degree in Clinical Research Administration and a Bachelor of Pharmacy degree in Pharmaceutical Sciences. In addition, he is a Certified IRB Professional (CIP) and is Regulatory Affairs Certified (RAC).

 

IRBMED Appoints New Assistant Director 

March 31, 2022

IRBMED is pleased to announce that Amy Skyles, PharmD has accepted the role of assistant director, effective March 28, 2022. Skyles has impressive IRB experience, serving as a full board member for IRBMED since 2006 when she also practiced as a clinical pharmacist in the Investigational Drug Service/Research Pharmacy (IDS/RP) at Michigan Medicine. She joined IRBMED as staff in 2020 as a Principal Associate Regulatory Analyst II and most recently served as interim assistant director. Skyles’ significant experience as an IRB board member, research pharmacist, teacher, and mentor will be invaluable in her new role. 

 

Electronic Signatures for FDA regulated documents using SignNow

(Updated March 16, 2022)

The university’s E-signature Service, SignNow, has a version that is compliant with FDA regulations at 21 CFR Part 11. If you use SignNow to obtain signatures for FDA-regulated documents and don’t see this logo when logged into your SignNow account, please contact the ITS Service Center and let the E-Signature team know that your SignNow account needs to be updated. Research 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.

 

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HOW IRBMED SUPPORTS RESEARCH

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All Guidance

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.

 

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 per 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.