2/21/2013: The HIPAA Privacy Rule guards patients' protected health information (PHI) and governs how researchers may access, use, and disclose PHI in research. This slide show provides a summary.
2/19/2013: The help text in section 9.2 of the standard informed consent template has been revised. The new text addresses child and elder abuse reporting.
2/7/2013: The IRBMED web site's guidance on Humanitarian Use Devices (HUDs) has been updated.
2/7/2013: Federal regulations outline requirements for obtaining the assent of human subjects under 18, as well as cases in which IRBs may wave those requirements. This short presentation offers an overview.
2/5/2013: The IRBMED web site now includes guidance on deception and concealment in human subjects research.
1/31/2013: The help text in section 6.1 of the standard informed consent template has been revised. This section relates to alternatives to study participation.
1/25/2013: The latest U-MIC presentation outlines the federal requirement for documenting subjects' consent to take part in research, as well as circumstances under which IRBs may waive the documentation requirement.
1/7/2013: IRBMED course offerings for February and March are now available; you may access the schedule of classes here: http://www.med.umich.edu/irbmed/education.html. Please note that the location for these classes has changed.
1/4/2013: IRBMED issues a bi-weekly email with information related to guidance updates, template modifications, staff changes, U-MIC postings, and available educational opportunities. If you would like to receive these emails, please contact Joseph Austin at firstname.lastname@example.org and let him know you would like to be added.
1/3/2012: The IRBMED Calendar has been updated to include scheduled Board meetings, educational opportunities, and holiday closures. You may access the calendar here: http://med.umich.edu/irbmed/StaffContactList.html#calendar
1/2/2013: Help text changes have been made to Sections 5.2 and 8.1 of the Informed Consent Template. These Sections relate to subject-injury language for internal or investigator sponsored projects. To view the help text, access the Informed Consent Template here: http://med.umich.edu/irbmed/ict.htm
11/28/2012: U-MIC UPDATES: Federal regulations guide IRBs in determining whether investigational medical devices present significant or nonsignificant risk to subjects. This short presentation offers an overview.
11/21/2012: BLINDED STUDIES IN MyUofMHealth.org: For BLINDED research studies, where subject access to their TEST RESULTS through MyUofMHealth.org MUST NOT BE VIEWED, contact IRBMED for special procedures to follow at 734-763-4768 or at email@example.com – or see Guidance for Blinded Studies (hotlink).
11/2/2012: U-MIC UPDATES: This slide show provides an overview of the Genetic Information Nondiscrimination Act (GINA), which prohibits health insurance companies and employers from discriminating based on genetic information.
10/18/2012: U-MIC UPDATES: Community-based participatory research (CBPR) involves the collaboration of academic researchers and members of the general community. This short presentation provides an overview.
10/4/2012: STAFF UPDATES: Claudia Krcmarik, BS, has accepted the role of Junior Associate Regulatory Analyst.
9/25/2012 WEB SITE UPDATES: We have recently redesigned our ORIO reporting guidance page. Our About IRBMED page now includes a link to some frequently asked questions about IRB requirements and procedures.
9/24/2012: U-MIC UPDATES: This slide show is the second of two tips summarizing Department of Defense regulations for human subjects research.
8/8/2012: U-MIC UPDATES: This first of two companion presentations on Prisoners as Research Subjects defines key terms and outlines the federal regulations governing enrollment of prisoners as subjects in research. Our next presentation will examine state and federal certification and the IRB's role in studies involving prisoners as subjects.
8/1/2012: U-MIC UPDATES: Guest U-MIC presenter Diane Lehman Wilson, MPP, JD, from the Office of Regulatory Affairs, provides an overview of the ClinicalTrials.gov registry, including requirements for registration and informed consent.
7/11/2012: STAFF UPDATES: Kate Sasamoto, JD, has accepted the position of ARA with the C1 Regulatory Team. Wendy Ulmer, BBA, former ARA for the C1 Regulatory Team, has accepted the position of JARA. Aaron Rankin, MSW, former ARA for the B1 Regulatory Team, has accepted the position of JARA.
7/11/2012: VICE-CHAIR UPDATES: Robertson Davenport, MD, has accepted the position of Vice-Chair for the C1 Board. Kevin Flaherty, MD, has accepted the position of Vice-Chair for the B2 Board.
7/11/2012: U-MIC UPDATES: Our new U-MIC slide show outlines Protected Health Information (PHI) requirements for researchers.
6/28/2012: U-MIC UPDATES: The lastest voiceover slide show in our U-MIC library covers anonymous, coded, and de-identified data in human subjects research.
6/22/2012: STAFF CHANGES: Pat Gordon, IRBMED Education Coordinator, has been designated as the Interim SARA for the B2 Regulatory Team. Patti Fritz-Hobson is the new JARA for the A2 Regulatory Team.
6/12/2012: U-MIC UPDATES: U-MIC now offers a brief slide show on Electronic Data Security.
5/31/2012: U-MIC UPDATES: We have recently added two new U-MIC presentations to our Education & Training pages: a short video on Privacy and Confidentiality and a voiceover slide show outlining NIH's Certificates of Confidentiality. To access all U-MIC presentations, click here.
522/2012: MULTIMEDIA EDUCATION & TRAINING: THE UNIVERSITY OF MICHIGAN IRB COLLABORATIVE (U-MIC): Our Education & Training pages feature slide shows and videos designed for both researchers and IRB members. Click here to view all released presentations, as well as a list of planned topics.
4/30/2012: CHANGES TO THE HSIP FORM: The Human Subject Incentives Program (HSIP) request form now enables users to attach and upload a spreadsheet or PDF with subject details directly into the request. Many of you may currently submit subject details to the HSIP office as an email attachment, which creates electronic records in an additional system. Uploading them directly into the HSIP request form eliminates these additional records and streamlines the HSIP process. HSIP recommends that you begin using the new file attach mechanism in the HSIP system immediately to submit your subject details. The HSIP office will no longer accept e-mail attachments as of Friday, May 11, 2012. The HSIP job aid in MyLINC has been updated with information on how to use the new file attach functionality: https://maislinc.umich.edu/mais/pdf/HSIP_PmtRequest_Create_SS.pdf. Please contact firstname.lastname@example.org if you have any questions.
4/16/2012: STAFF CHANGES: Judith Birk, former Director of IRB-HSBS, has accepted the position of Director for IRBMED. Carol Hutsko, former JARA for the A2 Board, has accepted the position of SARA for the B1 Board
4/16/ 2012: CONTACT INFORMATION: IRBMED has created a new Contacts page with contact information for IRBMED Co-Chairs, Vice-Chairs, and staff. There are also links to search by medical specialty or by team. You can access the new page by selecting About IRB in the left box or by clicking here.
4/11/ 2012: EDUCATION & TRAINING VIDEO UPDATE: We have added a new slide presentation to our Education & Training Videos page. This four-minute presentation explores using eResearch notes as reminders to complete all required sections of your application before submitting it to IRBMED.
4/10/2012: GLOSSARY: IRBMED has compiled a glossary of regulations, terms, and acronyms related to human subjects research. The contents of this glossary have been collected from a variety of authoritative sources. You can access the glossary by selecting Guidance on the IRBMED Homepage or by clicking here.
4/2/2012: EDUCATION & TRAINING: IRBMED is pleased to announce the initial roll-out of the new Education & Training Program, effective immediately. Over the next several months, we will continue to open new course offerings, so please check back for updates. To view the redesigned education pages and course offerings, please click here.We would like to thank all of the members of the research community who provided direction, guidance, and feedback while we developed this new educational model. We are committed to ensuring that this program is tailored to meet the needs of the research community, and look forward to continued collaboration.
3/20/2012: ADVERSE EVENT DEFINITIONS: Our guidance page now includes a direct link to OHSR’s adverse event terminology. Researchers use these terms to identify events’ severity, expectedness, and relatedness to research.
3/6/2012: MiChart: On February 29, 2012, the MiChart team at MICHR released a newsletter with information regarding the use of MiChart in relation to ongoing and future research projects. For more information or to access the newsletter, click here: http://www.med.umich.edu/i/michart/ Please direct any questions to: MiChart-Questions@umich.edu.
2/10/2012: EDUCATION & TRAINING: Our education team is currently collaborating with members of the research community in order to redesign IRBMED’s education program. The goal is to make sure this new program is tailored to meet the needs of the research community, and we are dedicated to entirely replacing the existing curriculum and offerings.
1/31/2012: CONSULTATIONS: IRBMED offers consults on various human subjects’ research protection topics. These educational consults are designed for small groups (typically less than 10 people). For information about what topics are offered or to request a consult, click here.
1/16/2012: MEET THE IRBMED: Thank you to all who attended. We appreciated all of the great questions and hope that the session was beneficial. If you would like to review the presentation, you may access it by clicking here. A list of the Questions and Answers will be available soon. We would also like to especially thank the panelists for sharing their knowledge and expertise and all of the people that worked behind the scenes to make this event a success.
1/4/2012: PRIVACY BOARD: Under Education on the Privacy Board page, discussion points, questions, and PowerPoint slides from October 18th's Research Privacy and HIPAA panel discussion are now available online.
1/3/2012: LEGACY SYSTEM HAS BEEN DISCONTINUED: IRBMED has ended all support for studies managed through the Legacy (paper) application system. The IRBMED office has administratively terminated all Legacy projects that were not migrated to the electronic system (eResearch) before December 23, 2011. If your study has been administratively terminated, you must suspend all research activities (such as enrollment, data collection, and data analysis) until you have re-submitted the study using eResearch and obtained IRBMED approval.
1/3/2012: NOMINATIONS FOR IRBMED VICE-CHAIR: Nominations for an IRBMED Vice-Chair are currently being solicited to fill the position vacated by Dr. Alan Sugar; Dr. Sugar was recently appointed a Co-Chair and is serving alongside Dr. Michael Geisser.
1/3/2012: MEET THE IRBMED: There will be a brief presentation followed by an open Question and Answer period.
For Notices prior to 2012, please visit our Releases and Updates to IRBMED Website Archive.