Releases and Updates to IRBMED Website

2/10/2012: EDUCATION & TRAINING: You asked and we listened!  Our education team is currently collaborating with members of the research community in order to redesign IRBMED’s education program.  Our 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. What should you expect?  Over the course of the next couple of months, you may notice a decrease in class offerings as we bring the current program to an end and prepare to launch the Education & Training Program.  We expect initial rollout of the new design to begin in early April. What makes the Education & Training Program different?  Beginning in April and continuing for the next several months, the number of class offerings will significantly increase from the current options.  Classes will be structured to provide varying levels of information based on needs and experience level.  The courses will also be facilitated by a consortium of subject matter experts with the knowledge to address your questions. How can I get involved?  IRBMED will be hosting two Open Forums for the research community where we will provide information regarding the proposed Education & Training Program, and various initiatives that are presently underway.  This will be an opportunity for you to evaluate the new design, review content, and provide our staff with feedback and suggestions.  More information regarding these Open Forums will be available shortly.

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. An IRBMED Vice-Chair should be a respected member of the faculty with the qualifications of a scientist member of the IRBMED. He or she should be concerned about human subject protections and related ethical issues, and be well-informed in regulations relevant to the use of human subjects in research. Ideally, Vice-Chair candidates should be either current or former IRBMED members. Vice-Chairs are appointed for a three-year term, renewable twice, for a maximum of three consecutive three-year terms. The Medical School will provide 15 percent salary support for this appointment. Please submit nominations to Dr. Raymond Hutchinson (rhutchin@med.umich.edu) by January 31, 2012.

1/3/2012: MEET THE IRBMED: Please join us on:January 16, 2012, from 11:30 a.m. to 1:00 p.m. at Ford Auditorium. Panel Members: Robertson Davenport, MD, Board Member; Jan Hewett, JD, BSN, IRBMED Director; and Alan Sugar, MD, IRBMED Co-Chair. There will be a brief presentation followed by an open Question and Answer period.  To register for this session, please visit: https://www-a1.lsa.umich.edu/es_conf/app/DisplaySession.asp?sessionid=5959.  If you would like to submit your questions in advance, please send them to Monica Stiddom at mhealy@umich.edu.

11/14/2011: NOMINATIONS FOR SERVICE ON IRBMED: Email your CV or resume with a letter of interest stating your reasons for volunteering to Jan Hewett, Director, IRBMED, c/o Board Secretaries: Colleen Bouton or Maria Camilleri. IRBMED is currently in need of 'Community Members who are Non-Affiliated'. To be eligible for participation on the IRBMED as a community representative, neither the member nor any member of his/her immediate family may otherwise have a direct affiliation (i.e., as an employee, contractor, student in a degree program, or active emeritus faculty member) with the University. Immediate family includes spouse, parents, grandparents, children and grandchildren, brothers, sisters, mother-in-law, father-in-law, brothers-in-law, sisters-in-law, daughters-in-law, sons-in-law, adopted, half, and step members.

11/14/2011: FINAL NOTICE: END OF LEGACY SYSTEM: IRBMED is ending all support for studies managed through Legacy (paper) application system as of December 23, 2011.  All active Legacy projects must complete “Migration” to eResearch Regulatory Management (eRM).  Any studies that do not complete Migration will be Administratively Terminated December 23, 2011. Contact IRBMED Regulatory Staff (734-763-4768) for help with Migration. Migration involves a new eRM application with special “pointers” to alert the IRBMED Board that the new application is not a new project, but a Migration of a former Legacy project.  If a study is administratively terminated, no research activities (e.g. enrollment, data collection or analysis) may take place until the study is re-submitted in eRM and approved as if a brand-new project.

11/14/2011: STARS UNAVAILABLE: IRBMED's Speak To A Regulatory Specialist (STARS) program will be unavailable on Tuesday, November 22, 2011, while staff attend an office retreat. During this time, you may submit your questions via email. IRBMED staff will return to the office on Wednesday, November 23.

11/14/2011: ORIO GUIDANCE AND REPORTING: IRBMED recently made a change to the webpage that contains the ORIO Guidance and Reporting. The timeline and guidance has not changed, but the page has been updated for ease of use. Please contact Monica Stiddom (647-1969 or mhealy@umich.edu) if you have any questions regarding this change.

11/1/2011: HOLIDAY CLOSURES: As the weather grows colder and the holiday season approaches the IRBMED Office would like to remind you that: 1. IRBMED review boards do not meet on Thursday, November 24, 2011, Thanksgiving Day, or on Friday, November 25, 2011, the day following Thanksgiving. The Office as well will be closed on these two days. 2. The IRBMED Office will not be open for business during the holiday beginning the afternoon of December 23rd. The office will reopen on Tuesday, January 3, 2012, at 8:30 a.m. Campus mail will not be delivered during the holiday closure. 3. IRBMED review boards do not meet during the holidays (12/24/11 to 1/2/12). The last meetings of 2011 are Thursday, December 22, and Friday, December 23. The first meeting of 2012 will be Thursday, January 5, 2012 (Boards B1 and B2). Happy Holidays!

10/20/2011: IRBMED’s PANEL DISCUSSION ABOUT RESEARCH PRIVACY AND HIPAA. 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.

10/14/2011: IRBMED STAFF CHANGES: Aaron Rankin has been hired as the ARA of the B2 Board.

8/30/2011: REVISION TO THE INFORMED CONSENT TEMPLATE DOCUMENT AND INSTRUCTIONS: Changes were made to the format of the Informed Consent and Assent Template webpage and updated versions of the Consent and Assent Templates have been uploaded. The revised forms include easier to read Consent and Assent Completion Instructions as well as "clean" copies of the Consent and Assent Templates (without instructions). Additionally, as required by recent FDA mandate and US law, information regarding the posting of the study information on clinicaltrials.gov has been added to the Informed Consent form. The Informed Consent and Assent documents can be found at http://med.umich.edu/irbmed/ict.htm.

8/27/2011: IRBMED STAFF CHANGES: Cecilia Brenner, former ARA of the B2 Board, has accepted the JARA position of the B2 Board.

8/2/2011: IRBMED STAFF CHANGES: Pat Gordon, former JARA of the B2 Board, has accepted the eResearch Coordinator position.
Jennifer Galland has been hired as the Expedited Staff Reviewer.

8/2/2011: REVISION TO THE INFORMED CONSENT TEMPLATE DOCUMENT AND INSTRUCTIONS: Changes were made to the format of the Informed Consent and Assent Template webpage and updated versions of the Consent (coming soon) and Assent Templates have been uploaded. The revised forms include easier to read Consent and Assent Completion Instructions as well as "clean" copies of the Consent and Assent Templates with no instructions. Additionally, as required by recent FDA mandate and US law, information regarding the posting of the study information on clinicaltrials.gov has been added to the Informed Consent form. The Informed Consent and Assent documents can be found at http://med.umich.edu/irbmed/ict.htm.

8/1/2011: LEGACY: The Legacy (paper) Application System officially CLOSED on July 1, 2011. If you were unable to migrate your study prior to July 1, contact the IRB office immediately for instructions. The Legacy Migration documents can be found at http://www.med.umich.edu/irbmed/migration.html.

7/14/2011: Changes were made to the formate of the Informed Consent and Assent Template page. In addition, an updated version of the Assent has been uploaded. This change created an easier to read Assent Form Instructions as well as a 'clean' copy of the Assent Template with no instructions. Similar changes to the Informed Consent documents are in progress.

7/14/2011: Changes to the Guidance regarding the Routine Reporting of Audits, Inspections, Reports and Correspondence to/from Oversight Bodies/Agencies/Entity. The URL for the page has also been changed. Please update any bookmarks.

6/17/2011: NEW DSMP GUIDANCE FOR AHRQ PROJECTS: Effective May 6, 2011, the Agency for Healthcare Research and Quality (AHRQ) issued notice
requiring the use of Data Safety and Monitoring Plans for studies meeting the following criteria: That is either AHRQ-conducted or -supported; Involves interventions with human subjects; and Presents greater than minimal risk to the subjects. For IRBMED’s guidance related to this change, please see: http://www.med.umich.edu/irbmed/guidance/AHRQ_DSMPs.html.

4/13/2011: TELEPHONIC CONSENT GUIDANCE CHANGED: On 4/13/11 changes were posted on the IRBMED website to the Telephonic Consent Guidance. The revised Guidance can be found at: http://med.umich.edu/irbmed/ict/TelephonicConsent-4-13-11.html.

3/25/2011: A change was made to the Informed Consent Template. We changed the Privacy and Compliance telephone number from 1-888-296-2481 to 1-866-990-0111. If the old number is called, callers are redirected to the new number. The revised forms are located on the IRBMED website at: http://med.umich.edu/irbmed/ict.htm.

2/1/2011: FDA Part 11 Electronic Signature Certifications and Assessments for eResearch and CareWeb -- These documents can be located at: http://med.umich.edu/irbmed/guidance/21cfr11.html.

2/1/2011: Changes were made to the Informed Consent Template. These changes include: Addition of language regarding Subject Injury and Instructions regarding International Research. The revised forms are located on the IRBMED web-site at: http://med.umich.edu/irbmed/ict.htm.

11/22/2010: Standard Operating Procedures - Updated. Summary of Changes Document.

10/22/2010: The guidance regarding Clinical Trials Registration (ClinicalTrials.gov information) was updated.

10/14/2010: The Informed Consent Template has been revised to address a problem with the approval stamping and fix misplaced bullets in the Genetic Information Nondiscrimination Act (GINA) language in the embedded Comments in Section 5.1. The Informed Consent Template Instructions were also updated to reflect the same changes.

10/6/2010: An updated version of the Legacy appplication for migration to eResearch / previously approved Legacy studies was posted.

10/4/2010: Revised Informed Consent Template updated with new headers, new Research-Related Injury for Industry-Sponsored, Federally-Funded and Investigator-Initiated Internally Funded Projects language has been added to the Comments in Section 8.1, and new Genetic Information Nondiscrimination Act (GINA) language has been added to the Comments in Section 5.1. Study teams submitting a New Project Application will be required to use the new informed consent template. Study teams with a Currently Approved Application do not need to take any immediate action.  Study teams submitting an Amendment to a Currently Approved Application will be required to update the informed consent document using the new template .

6/23/2010: Revised the Privacy Board Website

4/6-7/2010: Revised Informed Consent Template Announcement.

3/23/2010: Updated the name change and web link for the Clinical Research Calendar Review & Analysis Office (CRAO), formerly the Clinical Research Billing Unit (CRBU)

3/18/2010: Updated the link to the Final Oct 2009 "Investigator Responsibilities - Protecting the Rights, Safety, and Welfare of Study Subjects"

2/24/2010: Standard Operating Procedures - Updated.

1/21/2010: Updated the Adverse Events (AEs), Other Reportable Information and Occurrences (ORIOs), and Unanticipated Problems Involving Risks to Subjects or Others (UaPs). Changed "UM Adverse Event Timetable to "UM Adverse Event Reporting Timetable." Changed "standard UM timetable" to "UM Standard Timetable" under "The Study-Specific AE Reporting Option" and "The 'Study-Specific' AE Reporting Option box.

1/21/2010: Reworded "Reports and Letters from Oversight Agencies" to "Reports and Letters from Oversight Bodies and Agencies. Updated the section to read: Reports to or from internal oversight bodies...should be submitted to the IRBMED for review according to the UM Standard Timetable for Adverse Event (AE) or Other Reportable Information or Occurence (ORIO) OR as required in the Study Specific AE Reporting Timetable which may allow for non-concurrent reporting.

1/21/2010: Changed the title of the "Study Specific Timetable" to "Study Specific AE Reporting Timetable."

1/21/2010: Updated the UM Standard Adverse Event Reporting page. Reworded "Study Specific Timetable" with Study Specific Adverse Event (AE) Reporting Timetabl in the second paragraph.. Reworded the first Event Type to oversight body or agency. Reworded the first timeline to "Concurrently (in relation to reporting) Reporting should occur in parallel or no later than five (5) calendar days to all oversight bodies or agencies."

1/20/2010: Reformatted the Study Specific Adverse Event Reporting Timetable and reworded the first timeline (deleted the word 'sooner') so it was in accord with the the second row of the table.

For Notices prior to 2010, please visit our Releases and Updates to IRBMED Website Archive.