12/18/2013 — U-MIC Update
In the first of two presentations on writing informed consent documents, IRBMED's technical writer offers some basic recommendations for crafting documents that are both readable and comprehensible to subjects.
11/1/2013 — Holiday and Seasonal Closings
As the weather grows colder and the holiday season approaches, the IRBMED Office would like to remind you that:
- IRBMED will be closed on Thursday, November 28th and Friday, November 29th for the Thanksgiving holiday.
- Additionally, IRBMED will close at the end of business on Tuesday, December 24th and will reopen at start of business on Thursday, January 2, 2014.
11/1/2013 — FDA INSPECTIONS OF INSTITUTIONAL REVIEW BOARDS
FDA conducts periodic, scheduled inspections of IRBs, to determine whether they are in compliance with current FDA regulations and laws and whether they are following their own written procedures. This short presentation gives an overview.
10/9/2013 – ENROLLMENT NUMBERS AT SCHEDULED CONTINUING REVIEW
IRBs and other research administration committees at U-M are adopting a single standard definition of enrolled. In the newest U-MIC slideshow, guest presenter Lark Speyer summarizes enrollment reporting in eResearch.
10/7/2013 — STAFF UPDATES
/Cecilia Brenner, current JARA for the B2 Regulatory Team, will be taking on the role of Secondary Use and Umbrella Applications reviewer. Under this role, all new Secondary Use and Umbrella applications will be routed to Cecilia, thereby streamlining the review process for those projects. Aaron Rankin, MSW, will replace Cecilia as the JARA for the B2 team (effective October 7, 2013).
10/4/2013 — U-MIC Update
When research subjects make reference to individuals who are not involved in the study at hand, and with whom researchers have no interaction, we call these individuals third parties. The latest U-MIC presentation offers an overview.
10/4/2013 — STAFF UPDATES
IRBMED is pleased to announce that the position of Education Coordinator has been filled by Kate Sasamoto, JD. Kate is a current member of the IRBMED Staff, and will begin transitioning to the role of Education Coordinator on October 1, 2013.
IRBMED is also pleased to announce that Linda Cholewa, BS, has joined IRBMED as the ARA for the B1 Regulatory Team (effective September 3, 2013), and Nicole Duffy, BS, has joined as the ARA for the C1 Regulatory Team (effective September 9, 2013).
10/1/2013 — Federal Government Shutdown
For Information Relating to the Federal Government Shutdown, specifically in regards to funding and grant applications, please see the following:
|On Wednesday, October 2, 2013, the Staff at IRBMED will be attending the all-day educational FDA symposium, sponsored by Regulatory Affairs. Responses to emails and phone calls may be delayed as a result.|
9/30/2013 — Announcement Emails
Be sure to join the IRBMED Announcements Email list to receive important updates about educational opportunities, updates in guidances, or changes to templates. To sign up, click here: http://research.med.umich.edu/joinourlist
|Symposium on FDA-Regulated Research Don't miss this opportunity to get the "inside scoop" on the fascinating, and sometimes mysterious, world of FDA-regulated research. This symposium will feature insights from the perspectives of the clinical investigator, sponsor, IRB, and more — including a special presentation by an FDA inspector!
Please join us on Wednesday, October 2, 2013, 9 am — 4 pm, in the Rackham Amphitheater. Attendance is free, but space is limited — email firstname.lastname@example.org with your interest in attending.
This symposium is presented by the University of Michigan Office of the Vice President for Research and the Medical School Office of Regulatory Affairs.
SAVE THE DATE
Researchpalooza is scheduled for Wednesday August 21st, from 11:00am - 2:00pm. Spend some time learning about the latest collaboration and funding opportunities, and network with faculty and staff across dozens of specialties. Also, be sure to stop by and see the IRBMED table and meet some of our team members!
8/2/2013 — The IRBMED web site now includes information about ceding oversight to a central IRB. The Central IRB Information page (click the link in the navigation column to the left) contains a link to the slideshow used during the July 30 information session hosted by IRBMED and Chesapeake IRB, as well as a link to some frequently asked questions.
8/1/2013 — Join the "IRBMED Announcements" email list to receive important updates!
Are you interested in learning about the University of Michigan's procedures for using a central IRB for your multi-site, industry-sponsored clinical trials?
Representatives from IRBMED and from Chesapeake IRB, one of the central IRBs collaborating with the University of Michigan, are hosting an information session to discuss the application and review process for ceding IRB oversight to Chesapeake IRB. General highlights from the new UM eResearch Ceding Application and its review process will also be discussed.
To register for this event, click here: http://ttc.iss.lsa.umich.edu/ttc/sessions/upcoming/
Tuesday July 30, 2013
1:00pm – 2:00pm
Judith Birk, JD
6/28/2013 — Humanitarian Use Devices (HUDs) are used to treat conditions that affect fewer than 4,000 Americans per year. This short slide show outlines the requirements for HUD use and research.
6/13/2013 — The newest U-MIC presentation outlines requirements for IRB review of supporting documents at scheduled continuing review.
5/29/2013 — For the latest U-MIC presentation, guest presenter Lark Speyer offers an overview of projects lacking immediate plans for involvement of human subjects—known as umbrella projects.
5/21/2013 — IRBMED is moving! Beginning May 24, 2013, our new address will be:
2800 Plymouth Road
Building 520, Room 3214
Ann Arbor, MI 48109-2800
Our phone number and main email address will remain the same: 734.763.4768, email@example.com
Any mail directed to our current address will be forwarded to our new location.
IRBMED is NOT requesting amendments to update Informed Consent Documents (ICD) with the new address information. However, if you are submitting an amendment to modify some other aspect of the ICD, we request that you also update the address.
5/17/2013 — The latest U-MIC presentation offers recommendations for securing electronic research data.
5/3/2013 – Policy Change: IRBMED has a modified policy on watermarking and updating expiration dates on recruitment materials and informed consent documents at the time of scheduled continuing review (SCR). For studies where enrollment has concluded, IRBMED will no longer watermark or update expiration dates on recruitment materials at SCR. For studies where interaction/intervention with subjects has concluded, IRBMED will no longer watermark or update expiration dates on informed consent documents at SCR.
5/3/2013 — The newest U-MIC presentation addresses unanticipated problems involving risk to subjects or others.
5/1/2013 — The IRBMED web site now offers guidance on lotteries as incentives for research participation.
4/9/2013 – The Standard Informed Consent Template has been updated to include modified help text and language for:
- Genetic sub-studies
- Genetic Information Non-Discrimination Act (GINA)
Additionally, Section 12 – Signatures has been revamped entirely. The help text and language has been updated for clarity and consistency, and additional information has been included regarding:
- Two-parent signatures
- Genetic sub-studies
For the most up-to-date version of the ICD Template, click here.
4/9/2013 — 21 CFR Part 11 provides criteria under which FDA will consider electronic records to be equivalent to paper records and electronic signatures to be equivalent to traditional handwritten signatures. Click here for guidance, including certification letters and compliance checklists for MiChart, CareWeb, and eResearch.
4/3/2013 — The latest U-MIC slide show explores lotteries as incentives for research participation, including a summary of Michigan's legal requirements.
3/25/2013 — The newest U-MIC presentation outlines options for obtaining subjects' consent to take part in genetic sub-studies.
3/8/2013 – UMHS has updated its disciplinary policy for protecting patient information. This amended policy takes effect March 15, 2013. To read more, click here: http://umhsheadlines.org/08/health-system-updates-disciplinary-policy-for-protecting-patient-information/?utm_source=HSH&utm_medium=email&utm_campaign=TopStory-health-system-updates-disciplinary-policy-for-protecting-patient-information
3/7/2013 — IRBs maintain meeting minutes to document key elements of convened board meetings. This short presentation summarizes the requirements.
3/6/2013 — An informed consent template for use with Humanitarian Use Devices (HUDs) is now downloadable from the IRBMED web site.
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 latest 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.