A component of the University of Michigan's 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.
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.
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 per 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)