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A component of the University of Michigan's Human Research Protection Program (HRPP) and a unit of the Office of Research, the five Institutional Review Boards of the University of Michigan Medical School (IRBMED) oversee human subjects research conducted at the Medical School and UMHS. More >>  

  

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IRBMED News and Updates

June 22, 2017 — U-MIC

Principal Investigators have ongoing responsibilities after IRB approval of their study to ensure compliance with human subjects protections standards. Generally, these tasks can be performed by the investigator him or herself or delegated to qualified individuals. One of these primary responsibilities is monitoring the conduct and progress of the research study. A new two-part U-MIC presentation—developed in collaboration of the Office of Regulatory Compliance Review (ORCR)—provides an overview.

June 13, 2017 — NIH Genomic Data Sharing Policy: revised guidance

IRBMED has revised its online guidance on the NIH Genomic Data Sharing Policy, including instructions for IRBMED submissions.

Investigators receiving NIH funding for a study that generates “large-scale human genomic data” are generally required by the 2014 NIH Genomic Data Sharing (GDS) Policy to submit the genomic data to an NIH data repository in order to “ensure the broad and responsible sharing of genomic research data.”

June 5, 2017 — Statement of Practice: Sections 15 and 16 of the IRB Application

IRBMED has issued a new statement of practice pertaining to eResearch sections 15 (drugs and biologics) and 16 (devices).

Click here to view all IRBMED statements of practice.

May 9, 2017 — U-MIC update

The eResearch Regulatory Management system underwent a software upgrade on April 30, 2017. This upgrade brought about cosmetic and layout changes, as well as some minor changes in the software’s functionality. A new U-MIC presentation provides a summary of the changes.

April 27, 2017 — U-MIC updates

Several new U-MIC presentations have been developed and posted on the IRBMED website. These presentations address the following topics:

April 7, 2017 — Revised ICH-GCP Guidance

IRBMED has updated its guidance on International Council for Harmonisation Good Clinical Practice (ICH-GCP) guidelines.

Updates include a revised ICH-GCP checklist. Although researchers are encouraged to use the checklist to ensure that their research meets ICH-GCP requirements, it is no longer necessary to upload the completed checklist to eResearch.

March 30, 2017 — New Expanded Access Informed Consent Template

IRBMED has combined its Compassionate Use and Emergency Use informed consent templates to create a single FDA Expanded Access consent template. This new template may be utilized to develop consent documents in either Compassionate Use or Emergency Use situations. The Expanded Access consent template is available for download on the Specialty Informed Consent Templates page.

Physicians already utilizing approved consent materials based on the old templates are not required to submit an amendment to switch to the new template and may continue to use the materials approved by IRBMED.

March 16, 2017 — IRBMED SEMINAR SERIES

"Revisions to the Federal Policy for the Protection of Human Subjects ('Common Rule') – Changes Ahead"

Tuesday, April 4, 2017
9:00 AM - 11:30 PM
Ford Auditorium
University Hospital

Click here to register.

This installment of the IRBMED Seminar Series will focus on Revisions to the Common Rule issued by the Department of Health and Human Services on January 18, 2017.

While more information will be forthcoming, in this session we will provide an overview of the changes, the bulk of which are to become effective on January 19, 2018.

Light refreshments will be provided.

Click here for the seminar agenda.

March 6, 2017 — Updated ORIO Reporting Guidance

IRBMED has updated its guidelines for reporting of Other Reportable Information and Occurrences (ORIOs). As of March 6, 2017, these updated guidelines apply to all new and ongoing studies.

March 3, 2017 — eResearch Maintenance

UM Information Technology Services (ITS) has begun the process of upgrading the eResearch Regulatory Management system. Beginning Saturday, March 4, and recurring every week until the upgrade process is complete (ITS expects the process to take four to six weeks), the Regulatory Management system will be unavailable to users between 11 p.m. Saturday and 7 a.m. Sunday.

February 27, 2017 — Changes to IRBMED Fee Structure for Industry/Commercial Sponsors

Beginning April 3, 2017, the IRBMED fee for its review of new studies with industry/commercial sponsors will be raised from $1,800 to $2,500.  In circumstances where IRBMED will cede IRB oversight to an external IRB and the study has an industry/commercial sponsor, a new charge of $1,000 will be collected for IRBMED's efforts related to ceding review. These changes are based on a benchmarking effort conducted with other similar IRBs.  Implementation will affect contracts finalized after April 3, 2017.

February 27, 2017 — Revisions to the Common Rule (45 CFR 46 Subpart A)

On January 18, 2017, the Department of Health and Human Services issued final revisions to the Common Rule. The bulk of these changes are to become effective on January 19, 2018. Changes regarding cooperative research will become effective January 20, 2020.

While the University of Michigan is eager to implement these changes, because of the timing of the release of the Final Rule, it could be nullified under the provisions of the Congressional Review Act (CRA).

For important information about changes to the Common Rule and its implementation, read the Notification to U-M's Research Associate Deans from Dr. Jack Hu, Vice President for Research and Institutional Official for Human Subjects Research.

The upcoming IRBMED Seminar Series on Tuesday, April 4, 2017, from 9:00 to 11:30 AM in Ford Auditorium of the University Hospital, will include more information about the Common Rule revisions.

Click here to register for the event.

February 27, 2017 — SMART IRB

In December 2016, the University of Michigan signed the SMART IRB Master Common Reciprocal Institutional Review Board Authorization Agreement.  SMART IRB is a platform designed to ease common challenges and burdens associated with initiating multisite research and provide a roadmap for institutions to implement the NIH Single IRB Review policy. Through a flexible master IRB reliance agreement, standard operating procedures, and complementary tools and resources, SMART IRB supports and encourages collaboration and harmonization across the nation.

February 27, 2017 — Giving Copies of Informed Consent Documents to Subjects

Unless a waiver of documentation of informed consent is requested and approved by the IRB, subjects should be given a copy of the informed consent document.

Giving subjects signed copies of the informed consent document is mandatory

  • when the protocol states the study is to be conducted under ICH-GCP guidelines
  • when research involves access, use, and/or disclosure of subjects' protected health information (PHI) and HIPAA authorization is integrated into the consent document

FDA regulations do not require the subject's copy to be a signed copy, although a photocopy with signature(s) is preferred. In addition:

  • the original signed consent document should be retained in the study records.
  • to assure consent took place prior to study activities, the consent document should be dated by the subject/representative when signed. (If consent takes place the same day that subject involvement begins, medical records/case report forms should document that consent was obtained prior to the subject's participation in the research.)

February 20, 2017 — Standard Informed Consent Template (ClinicalTrials.gov)

The Office of Regulatory Affairs has recently recommended changes to the Privacy and Confidentiality portion (section 9.2) of IRBMED's standard informed consent template to guide researchers in complying with ClincialTrials.gov registration requirements.

These changes apply only to template instructions, which appear in light-blue boxes. Researchers who have received IRBMED approval to utilize consent materials based on the template prior to this update are not required to submit an amendment incorporating these changes, and may continue to use the consent materials approved by the IRB.

February 7, 2017 — NIH Genomic Data Sharing Policy Guidance

The IRBMED web site now offers guidance relating to the NIH 2014 Genomic Data Sharing (GDS) Policy, which was issued in 2014.

January 25, 2017 — Upcoming Changes to ORIO Guidelines (Effective March 6)

IRBMED is updating its guidelines for reporting of Other Reportable Information and Occurrences (ORIOs).  This update will become effective Monday, March 6, 2017.  The guidelines will be applicable to all new and ongoing studies.

January 23, 2017 — Revisions to the One-Time Blood or Specimen Sample Consent Template

IRBMED has revised its One-Time Blood or Specimen Sample Consent Template, which is available for download on the Specialty Informed Consent Templates page. The changes are as follows:

  • The term "tissue sample" has been replaced with "specimen sample" throughout the document.
  • The following statement, drafted by the University of Michigan Medical School Conflict of Interest Board (MEDCOI), has been added to the template:

UM researchers are always looking for new ways to treat diseases. It is possible that your data or blood samples could one day lead to an invention from which the University, researchers, or others could financially benefit.

Researchers who received IRBMED approval to utilize consent materials based on this template prior to the revision are not required to submit an amendment incorporating these changes, and may continue to use the consent materials approved by the IRB.

December 6, 2016 — IRBMED Website Changes

The Office of Research will begin its website migration on Tuesday, December 6. This will result in new web addresses for all IRBMED pages. Following this process, existing links to most IRBMED pages will automatically redirect to the Office of Research website.

If you maintain bookmarks and links to the IRBMED site, it will be necessary to update them once the three-day website migration process is complete.

For assistance or further information, please contact IRBMED, at 734-763-4768 or irbmed@umich.edu.

November 23, 2016 — IRBMED Website Changes

During the week of December 5, the IRBMED website will undergo changes resulting in new web addresses for all IRBMED web pages. During and after this process, IRBMED's main page will automatically redirect to the updated address; links to all other IRBMED pages, however, will redirect to the Office of Research website.

Please visit IRBMED's main page (/office-research/institutional-review-boards-irbmed) during the week of December 5 to be redirected to the updated site.

November 21, 2016 — eResearch Cross-Reference Table

IRBMED has updated its eResearch Cross-Reference Table to reflect recent changes in the eResearch application system.

November 21, 2016 — Holiday Hours

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 24th, and Friday, November 25th, for the Thanksgiving holiday.
  • Additionally, IRBMED will close at the end of business on Friday, December 23rd, and will reopen at start of business on Tuesday, January 3, 2017.

November 16, 2016 — New IRBMED Course Schedule for 2017

The IRBMED Education page has been updated to include courses that will be held between January and May 2017. Additional courses, if added, will be accompanied by an announcement (see email list below). Classes for the rest of 2017 will be posted mid-year.

November 16, 2016 — Next IRBMED Seminar Series- Save the Date!

The next installment of the IRBMED Seminar Series will occur on April 4, 2017, from 9:00 to 11:30 AM in the Ford Auditorium of UH. The session topic has not yet been determined; check here in the months ahead for further information.

You can reach the registration page by clicking here.

November 16, 2016 — IRBMED Announcements Email List

If you have not already done so, please sign up for the IRBMED Announcements Email List to receive important updates regarding future educational opportunities, guidance updates, or template changes.  To sign up, click on this link:  http://research.med.umich.edu/joinourlist

September 26, 2016 — IRBMED SEMINAR SERIES

"Phase I Clinical Trials and Safety: Consideration of a Subject's Death in France"

Tuesday, October 4, 2016
2:00 PM - 4:30 PM
Danto Auditorium
Cardiovascular Center

Click here to register.

IRBMED is excited to be hosting the next installment of our Seminar Series, with a focus on Phase I clinical trials and reporting of serious adverse events.

This will include a mock IRB session, which will provide insight into how an IRB would review a study where injuries occurred. This will be followed by a Q&A session with our IRBMED Board Members. 

Light refreshments will be provided.

Click here for the seminar agenda.

 

September 21, 2016 — STAFF UPDATE

Megan Boyt, M.Ed., CIP

Megan has accepted the role of Intermediate Associate Regulatory Analyst I for the A2 regulatory team.

Megan earned a Bachelor of Science (B.S.) degree in Elementary Education and a Master of Education (M.Ed.) degree in Instructional Technology. Additionally, she holds a "Certified IRB Professional (CIP)" certification from PRIM&R. Prior to IRBMED, Megan worked as a Research Compliance Specialist at Wayne State University. 

August 15, 2016 — RESEARCHPALOOZA

Wednesday August 31, 2016

Join the UMMS Office of Research for Researchpalooza during the annual Ice Cream Social, with more than 75 exhibitors from labs and offices of the Medical School and across campus. There will be ice cream, popcorn, games, and lots of giveaways.

August 12, 2016 — STAFF UPDATES

Linda Rowse, MBA

Linda recently accepted the role of Meeting Minutes Writer for IRBMED. Linda holds a Master of Business Administration and a Bachelor of Science in Microbiology, with a minor in Biochemistry. Prior to joining IRBMED, Linda wrote regulatory documents for the pharmaceutical and biotechnical industry. She also has worked as a bench scientist at Parke-Davis/Pfizer in neurodegenerative diseases and at the University of Michigan for the Department of Microbiology and Immunology.

Julia Ryan, RD, CDE 

Julia, a registered dietitian and certified diabetes educator, has accepted the role of Junior Associate Regulatory Analyst I for the B2 Regulatory Team.

New to IRBMED, Julia has 15 years of experience in various roles as a dietitian, most recently working for Aegerion Pharmaceuticals coaching individuals with Homozygous Familial Hupercholesterolemia (HoFH). She earned a BS in Food and Nutrition in 2000 and is beginning a Masters of Clinical and Pre-Clinical Research in August 2016. 

July 8, 2016 — U-MIC

In June 2016, the National Institutes of Health issued a formal policy regarding use of a single institutional review board (or sIRB) for multisite research. A new U-MIC presentation summarizes the policy.

June 21, 2016 — STAFF UPDATES:

Allison Kanous, BS

Allison, former temporary Meeting Minutes Writer for IRBMED, has accepted the role of Junior Associate Regulatory Analyst I for the B1 regulatory team.

Allison has been working with IRBMED since September 2015.  Allison holds a Bachelor of Science (B.S.) degree in Psychology as well as inter-disciplinary minors in both Cognitive Science and Bioethics, Humanities and Society.  Prior to UM, Allison worked as an office manager for a neurofeedback clinic, as a study coordinator in a neuroscience lab at MSU, and as a research assistant in the Burt Twin Registry at MSU.

Monica Stiddom, BA, CIP

Monica, former Assistant Regulatory Analyst, has been promoted to the role of Junior Associate Regulatory Analyst II for the B2 regulatory team.

Monica has been with IRBMED since May 2010, and has over six years of experience in various IRB operations.  Monica earned a Bachelor of Arts in Business Administration and holds a "Certified IRB Professional (CIP)" certification from PRIM&R.  Monica has worked at UM for more than 20 years, including experience at the Michigan Institute for Clinical and Health Research (MICHR), as well as time in Pediatric Endocrinology and in Audiology.

Beth Vibbart, BS

Beth, former Assistant Regulatory Analyst for the A2 and B1 regulatory teams, has been promoted to the role of Junior Associate Regulatory Analyst II for the A2 team.  

Beth has been with IRBMED since January 2014, first as the Board Secretary, then as an Assistant Regulatory Analyst.  Beth earned a Bachelor of Science in Sociology and a Certificate in Child Development.  Prior to IRBMED, Beth worked as a Clinical Clerkship Coordinator and Residency Program Assistant for the Department of Ophthalmology and Visual Sciences.

June 7, 2016 — ICH-GCP Guidance

IRBMED has developed new guidance on International Council for Harmonisation Good Clinical Practice (ICH-GCP) requirements. The new guidance addresses pertinent changes both to eResearch and to IRBMED's standard informed consent template and includes a link to a newly developed ICH-GCP checklist for investigators whose research is subject to ICH-GCP requirements.

June 7, 2016 — Updates to IRBMED's Standard Informed Consent Template

A new version of the standard informed consent template is now available for download on the IRBMED website. Template changes include

  • new blue-box help text in section 4 (study procedures) for research that involves genomic data sharing, including research subject to the NIH Genomic Data Sharing Policy
  • orange-box help text throughout the document for research subject to ICH-GCP requirements
  • changes to the legally authorized representative (LAR) signature box in section 12

June 2, 2016 — STAFF UPDATES:

Purna Garimella, MS, CIP, RAC

Purna, former Junior Associate Regulatory Analyst for the B2 regulatory team, has been promoted to the the role of Senior Associate Regulatory Analyst for the B2 team.

Purna has been working directly with IRBMED since Jan 2011, and has over five years of significant and diverse experience with IRBMED operations.  Purna holds a Master of Science (M.S.) degree in Clinical Research Administration as well as a Bachelor of Pharmacy degree in Pharmaceutical Sciences. In addition, he holds a "Regulatory Affairs Certification (RAC)" from the RAPS and is a "Certified IRB Professional (CIP)" from the PRIM&R.

 

Ann Dillon, BS, CIP

Ann, former Junior Associate Regulatory Analyst for the A1 regulatory team, has been promoted to the role of Intermediate Associate Regulatory Analyst for the A1 team.  

Ann has been with IRBMED since December 2010, and has over five years of experience reviewing IRB applications.  Ann earned a Bachelor of Sciences in Clinical Laboratory Science and holds a "Certified IRB Professional (CIP)" certification from PRIM&R.  Prior to UM, Ann worked as a drug safety coordinator for a large CRO, as a medical technologist in the blood bank at St. Joseph Mercy Hospital, and as a study coordinator at the UM School of Public health.

May 26, 2016 — U-MIC: Mobile Medical Apps

In February 2015, the Food and Drug Administration issued guidance pertaining to mobile medical applications. More recently, UM has added mobile medical app–related sections to the eResearch application system. The newest U-MIC slide show provides an overview of regulatory considerations regarding mobile medical apps.

May 13, 2016 — IRBMED Education Schedule

The Education page has been updated to include all courses through December 2016.

May 12, 2016 — U-MIC: ICH-GCP Requirements

The International Council on Harmonisation (ICH) brings together the drug regulatory authorities and the pharmaceutical industry of Europe, Japan, and the United States. ICH offers many benefits to regulatory authorities and the pharmaceutical industry, and ultimately promotes the protection of public health. The newest U-MIC presentation summarizes ICH-GCP requirements.

March 14, 2016 — IRBMED Seminar Series

The next installment of the IRBMED Seminar Series will occur on October 4, 2016, from 2:30 to 4:00 p.m. The session topic has not yet been determined; check here in the months ahead for further information.

January 27, 2016 — Updated De-Identified Data Sets Guidance

The Privacy Board's online guidance regarding de-identified data sets has been revised. Click here to see the updates.

January 12, 2016 — Updates to Central IRB Information

The Central IRB Information page now includes two updated Quorum Review IRB documents:

Note that UM researchers working with Quorum Review IRB are no longer required to insert UM boilerplate language into the Quorum-approved informed consent form. Quorum will add the UM language for study teams at the time of site approval.

January 8, 2016 — New Course Schedule

The IRBMED Education page now includes a schedule of courses between January and May 2016. Check back in the months ahead for courses scheduled throughout the remainder of 2016.

January 7, 2016 — U-MIC: HRPPs and AAHRPP

The Human Research Protection Proram (HRPP) has become an essential component of ensuring human subjects protections. The Association for the Accreditation of Human Research Protection Programs (AAHRPP) is an international, independent, nonprofit organization that reviews and accredits HRPPs. Since 2008, the University of Michigan has been an AAHRPP-accredited institution and is currently in the process of seeking reaccreditation.

Two new U-MIC presentations provide overviews of HRPPs and AAHRPP accreditation.

 

 

December 23, 2015 — SAVE THE DATE!

IRBMED Seminar Series:

Human Subject Protection Program Reaccreditation (AAHRPP)

&

Proposed Changes to the Federal Regulations (NPRM)

Friday, January 29, 2016

 

9:00am - 11:30pm

 

Danto Auditorium Cardiovascular Center

IRBMED is excited to be hosting the next installment of our Seminar Series, focusing on the Human Subject Protection Program reaccreditation and the proposed changes to the federal regulations.

IRBMED will also host a mock IRB session, which will provide insight into how IRBs review studies. For this session, we will review a comparative effectiveness trial. This will be followed by a Q&A Session with several of our IRBMED Board Members.

Click here for the seminar agenda.

Space is limited, so be sure to register here: http://ttc.iss.lsa.umich.edu/ttc/sessions/irbmed-seminar-series-3/

 

 

December 22, 2015 — IRBMED Education Schedule

The Education page has been updated to show courses scheduled January 2016. Courses scheduled for the remainder of 2016 will be posted shortly.

December 17, 2015 — Opportunity to Submit Comments on Proposed Common Rule Changes

As you may already know, the Department of Health and Human Services recently proposed revisions to federal regulations (called the Common Rule) which govern federally funded human subjects research, and requested comments on the revisions. You have an opportunity to comment by January 6, 2016.

The proposed changes issued in a Notice of Proposed Rule Making (NPRM) will broadly impact research, including a welcomed change to eliminate continuing review for minimal risk research. Importantly, the changes include a proposal to expand the definition of a human subject to include all biospecimens (e.g., urine, blood, biopsy specimens), regardless of whether or not they contain any identifiers about the person from whom they were obtained. Their utilization would almost always require informed consent for research use and significantly impact research with biospecimens. Currently, IRBs are able to waive informed consent in many of these circumstances.

Note: This is a proposed rule - it is NOT yet final.

Comments made through regulations.gov website on the impact of the proposed revisions will be accepted until 11:59 PM ET on January 6, 2016. The University of Michigan is submitting a response on behalf of its entire Human Research Protection Program (HRPP). Submission of your individual comments reflecting direct impacts of these changes upon your research are also important in this process.

To help you direct your comments, the following resources and additional information is available on the HRPP website at: http://research-compliance.umich.edu/respond-nprm

We also encourage you to contact your professional societies to assure that they provide relevant comments on this proposed rule change. If you have any questions, please contact Lois Brako at hrppumich@umich.edu.

November 20, 2015 —
CONSENT TEMPLATE UPDATE:Minor Changes to the Standard Informed Consent Template

The list in section 9.2 itemizing subject information that researchers may access, use, and disclose has been modified to mirror the list within section 25 of the eResearch application.

This change is applicable for the creation of new consent documents going forward. Previously approved consent documents do NOT need to be amended, nor do subjects need to be re-consented.

November 6, 2015 — Plain Language Medical Dictionary

The Plain Language Medical Dictionary widget, hosted by the University of Michigan Library, is a project of the University of Michigan Taubman Health Sciences Library as part of the Michigan Health Literacy Awareness project. The IRBMED Guidance page now links to this dictionary.

November 4, 2015 — Holiday Hours

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 26th and Friday, November 27th for the Thanksgiving holiday.
  • Additionally, IRBMED will close at the end of business on Thursday, December 24th, and will reopen at start of business on Monday, January 4, 2016.

November 3, 2015 — SEMINAR SERIES DATE CHANGE

 

The IRBMED Seminar Series previously scheduled for Friday, November 6th has been rescheduled for Friday, January 29th from 9am – 11:30am.  The Series will focus on upcoming changes to the conduct and oversight of human subjects research.

 

Space is limited, so be sure to register here: http://ttc.iss.lsa.umich.edu/ttc/sessions/irbmed-seminar-series-3/

 

July 22, 2015 — Repository Applications (REP)

 

Repository Application (REP) is a new submission type available in eResearch Regulatory Management (eRRM) for oversight of U-M data/biospecimen research repositories. A research repository stores, maintains, and distributes data and/or biospecimens to enable future research. New repositories should request IRB approval through an REP application for intake, storage, maintenance and distribution of data and/or biospecimens.

 

For further information on the IRB implementation of oversight through Repository Applications, on regulatory and policy background for repository oversight, and for additional U-M resources on repositories, see IRBMED website Repository Overview and sub-pages, as well as a new U-MIC presentation.

 

July 22, 2015 — U-MIC

 

A research data or tissue bank, or research repository, stores, maintains, and distributes data and/or biospecimens to enable future research. Making data and biospecimens available in repositories, to maximize their utility to the overall research community, is increasingly a priority at both national and institutional levels. The latest U-MIC presentation provides a summary.

 

July 16, 2015 — Working with Central IRBs

 

IRBMED has revised its Central IRB Guidance. Four updated documents reflect the most current procedures for University of Michigan personnel working with Chesapeake IRB, Quorum IRB, Schulman IRB, and Western IRB.

 

July 16, 2015 — eResearch Regulatory Management Guidance

 

IRBMED has updated its eResearch guidance to include links to various reference guides, a summary of general eResearch Regulatory Management workflow, and indicators for determining where an application is in its lifecycle.

 

June 15, 2015 — U-MIC

 

All institutions engaged in human subjects research that is not exempt from the regulations, and that is conducted or supported by any Department of Health and Human Services agency, must be covered by an Office for Human Research Protections (OHRP) approved assurance of compliance called a federalwide assurance or FWA. An institution may extend its FWA to cover a collaborating individual investigator or other institution. The latest U-MIC presentation outlines three different collaborator agreements.

 

June 15, 2015 — U-MIC

 

To utilize federal regulations’ existing flexibilityy regarding non-federally-funded, non-FDA regulated research, IRBMED has launched two new initiatives: Exemption 7 and two-year approval periods. A new U-MIC presentation summarizes these two initiatives.

 

June 12, 2015 —

 

IRBMED has recently implemented a submission intake process prior to routing applications to regulatory teams for review.  New studies submitted to IRBMED for review require the informed consent to be created using the most current informed consent template.  A preliminary review will be conducted to ensure that the most current version of the informed consent has been utilized.  If the most current version of the informed consent template has not been used, the eResearch application will be returned to the study team.  The study team will need to update the consent forms to the most recent template and resubmit.  The most current informed consent template is always available on the IRBMED website: /office-research/institutional-review-boards-irbmed/informed-consent-templates.

 

 

 

If you have any questions, please do not hesitate to contact the IRB for assistance.

 

 

 

June 12, 2015 — New Flexibility Initiatives

 

 

 

To utilize federal regulations’ existing flexibility regarding non-federally-funded, non-FDA-regulated research and the application of equivalent protections, IRBMED has launched two new initiatives: Exemption 7 and Two-Year Approval periods.  These initiatives will be applied at the discretion of IRBMED; study teams may not request that IRBMED grant either initiative to a research project.

 

 

 

IRBMED may now choose to grant Exemption category 7 to certain existing studies in which research activity is limited to analysis of a single dataset containing identifiable information; new applications are not eligible for Exemption 7 at this time.  This exemption eliminates the need for researchers to submit annual scheduled continuing reviews (or SCRs) when the only study activity is data analysis.

 

 

 

As its second new flexibility initiative, IRBMED may now opt to issue two-year approval periods for qualifying studies. The longer approval period eliminates the need for researchers to submit annual scheduled continuing reviews.

 

 

 

Click here for Statements of Practice addressing flexibility initiatives.

 

 

 

June 5, 2015 — Exempt Human Subjects Research Guidance Updates

 

 

 

IRBMED has revised its existing Exempt Human Subjects Research guidance and developed new guidance outlining federal exemption categories.

 

 

 

June 1, 2015 — Statement of Practice: PEERRS Certification Requirements

 

 

 

Current certification demonstrating a basic level of human subjects’ protection education is required for certain study team roles before IRBMED Approval or Exempt determination.

 

 

 

See IRBMED's Statement of Practice (effective April 20, 2015) for more details.

 

 

 

April 30, 2015 —

 

 

 

IRBMED would like to thank everyone that contributed their time, knowledge, and expertise in order to make the Seminar Series a success, with special thanks to all of our guest presenters.  To everyone that was able to attend, we hope you found the sessions to be informative and beneficial.

 

 

 

Copies of the presentations are available here: /office-research/institutional-review-boards-irbmed/irbmed-seminar-series

 

 

 

We look forward to planning our next IRBMED Seminar Series for Fall 2015!

 

 

 

April 20, 2015 — SAVE THE DATE!

 

 

 

IRBMED Seminar Series: Privacy and Confidentiality Tuesday, April 28, 2015 12:30pm - 4:30pm Danto Auditorium Cardiovascular Center

 

 

 

IRBMED is excited to be hosting the next installment of our Seminar Series, focusing on several contemporary issues related to privacy and confidentiality in research.  Topics will include: 

 

 

 

  • Anatomy of a Breach
  • Data Security and IT
  • Protecting Research Data: PI and Study Team Responsibilities 

 

 

IRBMED will also host a mock IRB session, giving insight into how our Boards review possible breaches of privacy and confidentiality.  This will be followed by a Q&A Session with several of our IRBMED Board Members.  Light refreshments will be provided.

 

 

 

Space is limited, so be sure to register here: IRBMED Seminar Series

 

 

 

April 20, 2015 — Statement of Practice: PEERRS Certification Requirements

 

 

 

A new Statement of Practice summarizes PEERRS certification requirements.

 

 

 

Click here to see all IRBMED Statements of Practice.

 

 

 

April 17, 2015 — Unanticipated Problems Involving Risk to Subjects or Others (UaP/UPRISO): Guidance Update

 

 

 

IRBMED has revised the Unanticipated Problem criteria on the UaP/UPRISO guidance page. The revisions reflect OHRP guidance.

 

 

 

April 17, 2015 — U-MIC

 

 

 

Occasionally, researchers have financial interests that create the potential for bias. This is referred to as a conflict of interest. The latest U-MIC presentation summarizes considerations for IRB reviewers when study team members have conflicts of interest.

 

 

 

April 3, 2015 — Updated Adverse Event Reporting Guidance

 

 

 

IRBMED has updated its guidelines for reporting internal adverse events. As of April 3, 2015, these updated guidelines apply to all new and ongoing studies that report internal adverse events according to UM's standard reporting schedule.

 

 

 

March 25, 2015 —

 

 

 

SAVE THE DATE!
IRBMED Seminar Series: Privacy and Confidentiality
Tuesday, April 28, 2015

 

 

 

12:30pm - 4:30pm

 

 

 

Danto Auditorium
Cardiovascular Center

 

 

 

IRBMED is excited to be hosting the next installment of our Seminar Series, focusing on several contemporary issues related to privacy and confidentiality in research.  Topics will include: 

 

 

 

  • Anatomy of a Breach
  • Data Security and IT
  • Protecting Research Data: PI and Study Team Responsibilities 

 

 

IRBMED will also host a mock IRB session, giving insight into how our Boards review possible breaches of privacy and confidentiality.  This will be followed by a Q&A Session with several of our IRBMED Board Members. 

 

 

 

Light refreshments will be provided.

 

 

 

Space is limited, so be sure to register here: IRBMED Seminar Series
 

 

 

 

March 24, 2015 — U-MIC

 

 

 

The University of Michigan Human Research Protection Program’s Operations Manual addresses the roles and responsibilities of researchers, including principal investigators, or PIs. The newest U-MIC presentation outlines these responsibilities.

 

 

 

March 24, 2015 — IRBMED Glossary Update

 

 

 

IRBMED has revised its glossary. Definitions of adverse event relatedness align with the Internal Adverse Event Reporting Guidance that becomes effective on April 3.

 

 

 

February 25, 2015 — Statement of Practice: External Adverse Event Reports and Unanticipated Problems

 

 

 

UM investigators participating in multi-site trials and those using sponsored agents routinely receive reports of external adverse events. Office of Human Research Protections (OHRP) guidance indicates that individual adverse events should only be reported to investigators at all participating institutions when the sponsor determines that the event meets the criteria for an Unanticipated Problem (UaP).

 

 

 

See IRBMED's new Statement of Practice for more details.

 

 

 

February 9, 2015 — Statement of Practice: Demonstration Project: Exemption 2A

 

 

 

Utilizing the flexibility of the regulations and in collaboration with IRB-HSBS, IRBMED proposes a new U-M demonstration project: Exemption 2A. This demonstration project will expand the definition of Exemption 2 to minimal risk research with adults that involves a non-invasive intervention followed by data collection via survey, interview (including focus groups), test, observation, and/or recording of physiological measurements.

 

 

 

 

 

 

 

A new Statement of Practice describes Exemption 2A.

 

 

 

January 30, 2015 — U-MIC

 

 

 

A few specific sub-categories of human subjects research are defined as “Exempt” from the federal regulations governing IRB operations. In addition, University of Michigan policy permits “flexibility initiative” Exemptions for some studies that are not federally funded or FDA-regulated. In the newest U-MIC presentation, guest presenter Lark Speyer provides a summary.

 

 

 

December 18, 2014 — Holiday Office Hours and Staffing

 

 

 

The IRBMED Office would like to remind you that IRBMED will close at the end of business on Wednesday, December 24th and will reopen at start of business on Friday, January 2, 2015. The office will have limited staffing on January 2, and return to standard staffing on Monday, January 5th. 

 

 

 

December 8, 2014 — U-MIC

 

 

 

The lastest U-MIC presentation examines what secondary use is as it relates to human subjects research and when the secondary use application type in eResearch is applicable.

 

 

 

December 1, 2014 — Holiday Office Schedule

 

 

 

As the weather grows colder and the holiday season approaches, the IRBMED Office would like to remind you that IRBMED will close at the end of business on Wednesday, December 24th and will reopen at start of business on Friday, January 2, 2015.

 

 

 

November 21, 2014 — 2015 IRBMED Education Schedule

 

 

 

The Education page has been updated to show all courses scheduled through November 2015. Courses scheduled for the remainder of 2014 are listed, as well.

 

 

 

November 12, 2014 — Expedited Category (5)

 

 

 

When research meets the appropriate federal criteria, IRBMED may apply Expedited Category (5) to research projects (or elements thereof) involving data/materials that either have been collected previously for research or non-research purposes and/or will be collected solely for non-research purpose.

 

 

 

A new Statement of Practice provides a full interpretation of Expedited Category (5).

 

 

 

November 11, 2014 — Expedited Category (8)

 

 

 

IRBMED may apply Expedited Category (8) to continuing review of research with any previously determined risk level. When the research meets criteria for category 8(a) or 8(c), the IRB member performing expedited review should determine that the ongoing and future research activity involves No More Than Minimal risk.

 

 

 

A new Statement of Practice provides a full interpretation of Expedited Category (8).

 

 

 

November 10, 2014 — eResearch Cross-Reference Table

 

 

 

IRBMED has developed an eResearch Cross-Reference Table to prompt study team members, IRB staff, and IRB board members to consider all locations throughout the IRB application where a given change may also need to be reflected elsewhere in the application materials.

 

 

 

Please review the Statement of Practice for more information.

 

 

 

November 4, 2014 Holiday Hours

 

 

 

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 27th and Friday, November 28th for the Thanksgiving holiday.
  • Additionally, IRBMED will close at the end of business on Wednesday, December 24th and will reopen at start of business on Friday, January 2, 2015.

 

 

October 31, 2014 — A newly developed document on IRBMED's Statements of Practice page addresses version control of informed consent documents.

 

 

 

September 23, 2014 — IRBMED would like to thank everyone that contributed their time, knowledge, and expertise in order to make the Seminar Series a success, with special thanks to all of our guest presenters.  To everyone that was able to attend, we hope you found the sessions to be informative and beneficial. 

 

 

 

Copies of the presentations are available here: /office-research/institutional-review-boards-irbmed/irbmed-seminar-series 

 

 

 

We look forward to planning our next IRBMED Seminar Series for Spring 2015!

 

 

 

September 23, 2014 — U-MIC 

 

 

 

To ensure that study teams modifying consent documents utilize the most recent IRB-approved version, IRBMED has standardized practices for version control of informed consent documents. The new U-MIC presentation summarizes the practices.

 

 

 

September 11, 2014 —  

 

 

 

SAVE THE DATE!
IRBMED Seminar Series: FDA-Regulated Research
Friday, September 19, 2014 

 

 

 

8:30am - 12:00pm
Danto Auditorium
Cardiovascular Center

 

 

 

IRBMED is excited to be hosting the next installment of our Seminar Series, focusing on several contemporary issues related to FDA-regulated research.  Topics will include: 

 

 

 

  • Challenges of FDA-Regulated Research
  • Mobile Apps as FDA-Regulated Devices
  • MIAP: Requirements for INDs and IDEs 

 

 

IRBMED will also host a mock IRB session, giving insight into how our  Boards review FDA-regulated research.  This will be followed by a Q&A Session with several of our IRBMED Board Members. 

 

 

 

Click here for the seminar agenda. 

 

 

 

Space is limited, so be sure to register here: Seminar Series Registration

 

 

 

 

 

 

 

September 8, 2014 — Informed Consent Version Control

 

 

 

To assure that study teams are utilizing the most recent IRB approved consent version when making modifications at the time of amendment, IRBMED has standardized practices for version control of informed consent documents.  The standardized practices include procedures for:

 

 

 

  • Accessing the most recent IRB approved clean version of the consent from the eResearch application in Section 10-1 (Word version)
  • Uploading only the track changes version as part of an amendment modifying the consent
  • Using standard naming conventions for uploading consent documents into eResearch

 

 

IRBMED will continue to closely review consent documents to verify that the most recently IRB approved version is being utilized.  When finalizing consent documents, IRBMED will add a verification number to each approved consent document.  This number will be included on the “clean” copy uploaded by IRBMED to Section 10-1 and on the watermarked PDF version.  Study teams may not alter this verification number.

 

 

 

For more information, click here

 

 

 

August 21, 2014 —

 

 

 

RESEARCHPALOOZA!

 

 

 

Come join the Office of Research on Wednesday August 27th, from 11am – 2pm, on Circle Drive in front of Med Sci I. 

 

 

 

Researchpalooza is the perfect opportunity for colleagues and friends to have a great time and meet, mingle, and learn more about many of the organizations that offer their services to faculty, students, and staff, all at one convenient time and location.  With nearly 70 participating offices and labs, it's shaping up to be a great event! 

 

 

 

Be sure to stop by and meet some of the IRBMED staff.  We’re looking forward to seeing you there!

 

 

 

For more information, click here.

 

 

 

August 21, 2014 —

 

 

 

The “Inside Scoop” on When the FDA Comes to Call

 

 

 

Wednesday, August 27, 2014
BSRB Kahn Auditorium
2pm – 3pm 

 

 

 

Nancy A. Bellamy, FDA Investigator, Bioresearch Specialist, Detroit Office, will be discussing issues of importance for human subject protection, how to run an FDA-compliant clinical trial, and what “observations” of concern are most commonly found during FDA inspections.  Her presentation will be followed by liberal time for questions and answers. 

 

 

 

This event is sponsored by UMMS Office of Regulatory Affairs.  There is no registration for this event. 

 

 

 

Click here for a presentation flyer.

 

 

 

August 21, 2014 — U-MIC 

 

 

 

In certain circumstances, IRBMED may permit the University of Michigan’s participation in a multi-site study only if U-M–specific protocol modifications are implemented. A new U-MIC presentation offers a summary of the procedures.

 

 

 

August 19, 2014 — Two New Specialty Informed Consent Templates 

 

 

 

IRBMED's Specialty Consent Templates page now offers two new templates: an Emergency Use Informed Consent Template and a Survey Research Informed Consent Template. The survey consent template is available both with instructions and in a clean version. Emergency Use guidance, including information about obtaining informed consent in emergency use situations, is available here

 

 

 

July 28, 2014 — Central IRBs

 

 

 

The University of Michigan has finalized Master Services Agreements with four IRBs: Chesapeake IRB, Quorum Review IRB, Schulman Associates IRB, and Western IRB (WIRB). Please visit the Central IRB Information page for details about ceding IRB oversight to one of these IRBs.

 

 

 

July 8, 2014 — New Specialty Informed Consent Template: Compassionate Use 

 

 

 

A newly developed Compassionate Use Informed Consent Template is now available for download on IRBMED's Specialty Consent Templates page. A Compassionate Use Information Sheet accompanies the new template, to guide and assist researchers in completing their compassionate use Informed consent document prior to submitting it to the IRBMED for review.

 

 

 

June 13, 2014 —

 

 

 

REGULATORY FLEXIBILITY:

 

 

 

Exemption 2A

 

 

 

Utilizing the flexibility within the human subject protection regulations and in accordance with our Federalwide Assurance (FWA) with OHRP,  IRBMED has expanded the definition of Exemption 2 to include minimal risk research with adults that involves a non-invasive intervention followed by data collection via survey, interview (including focus groups), test, observation, and/or recording of physiological measurements.  This expanded category is called Exemption 2a. 

 

 

 

Non-invasive interventions include, but are not limited to:

 

 

 

  • Reading a story or vignette
  • Playing an economic game
  • Using a computer program or website
  • Watching a video
  • Using a robot arm or mechanical object, if it remains outside of the body
  • Being exposed to stimuli such as color, light or sound (within safe limits) 

 

 

To qualify for this expanded definition of Exemption 2, the study must pose no more than minimal risk to subjects and may not include any of the following: 

 

 

 

  • Federal funding or federal training grants (direct or prime sponsorship)
  • FDA regulated components
  • Sponsor or other contractual restrictions
  • Clinical interventions (including clinical behavioral interventions)
  • Minors as subjects
  • Prisoners as subjects
  • Receipt of an NIH issued Certificate of Confidentiality to protect identifiable research data 

 

 

Initial or Scheduled Continuing Review applications meeting the criteria cited above will be reviewed by the IRB to determine that subject protections are equivalent to those required by federal regulations. If equivalent protections are in place, and there are no additional extenuating circumstances, IRBMED may issue the new Exemption 2A.  

 

 

 

All other regulatory requirements pertaining to exemptions remain unchanged. 

 

 

 

June 10, 2014 — HSIP Gift Cards

 

 

 

The Human Subjects Incentive Program (HSIP) has recently selected a new vendor, Vantiv, for issuing gift cards.  As part of this change, the program will now be distributing MasterCard gift cards instead of the previously distributed Visa gift cards.  IRBMED is not requiring that study teams submit amendments at this time to change this information in consent documents; rather, this change should be made with the next amendment submitted.

 

 

 

For more information, please see the HSIP website: http://www.finance.umich.edu/treasury/hsip

 

 

 

May 23, 2014 — 

 

 

 

IRBMED SEMINAR SERIES

 

 

 

Thank you to everyone that contributed their time, knowledge, and expertise in order to make the Seminar Series a success.  To everyone that was able to attend, we hope you found the sessions to be informative and beneficial.

 

 

 

Click on any of the following links to access the slide presentations:

 

 

 

 

 

May 8, 2014 — The Central IRB Information page includes a recently updated decision tree illustrating the workflow when ceding oversight to a non–UM Institutional IRB (typically an academic institution).

 

 

 

April 18, 2014 — Federal regulations and the University of Michigan Human Research Protection Program's Operations Manual address requirements for IRB membership and approval of proposed research at convened IRB meetings. The new U-MIC presentation offers a summary.

 

 

 

April 8, 2014 — 

 

 

 

SAVE THE DATE!

 

 

 

IRBMED SEMINAR SERIES

 

 

 

Ford Auditorium
May 21, 2014
1:00pm - 5:00pm

 

 

 

IRBMED is excited to be hosting the next installment of our Seminar Series, focusing on several contemporary issues related to conducting human subjects research.  Topics of discussion will include:

 

 

 

  • HIPAA: Crossing the Privacy Barrier
  • Central IRBs: Ceding IRB Oversight
  • Case Study: Managing Multi-Disciplinary Research
  • Social and Behavioral Research in the Medical Setting

 

 

The seminar will conclude with a Panel Q&A Session, with representatives from the IRBMED Co- and Vice-Chairs, Directors, and Staff.   For the full agenda, click here.

 

 

 

Seating is limited and registration closes on May 14th, 2014!  To save your space, be sure to register here: Seminar Series Registration

 

 

 

April 3, 2014 — In certain cases, it is possible to obtain legally effective informed consent in an urgent or emergency care setting. The new U-MIC presentation examines the variables that IRBs and researchers must consider when determining whether consenting emergency care patients for research is appropriate.

 

 

 

April 1, 2014 — Modification to Regulatory Oversight of Exempt Research Projects

 

 

 

Beginning April 1, 2014, IRB-HSBS (UM Central Campus IRB) will be taking on responsibility for processing some Exempt human research study applications submitted by UMHS or Medical School faculty.

 

 

 

Specifically, IRB-HSBS will review and issue the exempt determinations for Exempt Categories 1, 2, and 3, when study teams will not be accessing Protected Health Information (PHI).

 

 

 

IRBMED will retain oversight for Exemptions 1, 2, and 3, when the study team will be accessing PHI, and for all Exemptions 4, 5, and 6 originated by UMHS or Medical School faculty.

 

 

 

IMPORTANTLY, default jurisdiction for UMHS faculty is not changing: if you normally submit to IRBMED (by choosing "IRBMED" in question 1.9 of an HUM application), please continue to do so.

 

 

 

IRB staff will re-assign appropriate applications as necessary.  Please contact Lark Speyer, IRBMED Exempt/Not Regulated Coordinator, at larkspur@med.umich.edu with general questions. Contact the IRB "Staff Owner" with questions about any specific application.

 

 

 

March 20, 2014 — For minimal-risk research that falls under one of nine categories, federal regulations allow review by an IRB Chair or designee, with no vote by the full IRB. The new U-MIC presentation outlines category 5: research involving materials collected for non-research purposes.

 

 

 

March 11, 2014 — Central IRB Information

 

 

 

A new decision tree on the Central IRB Information page illustrates the workflow when ceding oversight to a non–UM Institutional IRB (typically an academic institution).

 

 

 

March 7, 2014 — The IRBMED web site now includes a Statements of Practice page. The first Statement—covering Approval Dates on Consent Documents and Recruitment Materials—is available here.

 

 

 

March 7, 2014 — In 2009, the Food and Drug Administration published guidance on the responsibilities of investigators conducting drug, biologic, and device trials. The new U-MIC presentation provides an overview.

 

 

 

February 21, 2014 — For each application it reviews—whether during a convened Board meeting or by expedited review—the IRB must make certain regulatory determinations. The latest U-MIC presentation offers a summary.

 

 

 

February 4, 2014 — Central IRB Information

 

 

 

A new decision tree on the Central IRB Information page illustrates the workflow when ceding oversight to an independent/commercial IRB.

 

 

 

January 23, 2014 — Central IRB Information 

 

 

 

The Central IRB Information page has been updated. Click here to view new and revised frequently asked questions. 

 

 

 

January 22, 2014 — Education Update 

 

 

 

The IRBMED Education Page has been updated with a new layout for improved readability.  On the new education page you will, also, find updated information regarding IRBMED’s course offerings.  Courses are now scheduled through the end of 2014 and course descriptions and the course grid have been revised to reflect new offerings and more accurate descriptions. 

 

 

 

January 15, 2014 — Specialty Informed Consent Templates 

 

 

 

The IRBMED web site now offers two new specialty consent templates for use by study teams.

 

 

 

The first new template is tailored to minimal risk studies that involve a single blood or tissue sample.

 

 

 

The second new template is designed for eligibility screening that poses no more than minimal risk to subjects. 

 

 

 

These specialty templates are not meant for use in studies involving genetic analysis of subjects' blood or tissue samples or when tissues or data will be submitted to a repository. 

 

 

 

January 15, 2014 — Web Site Update 

 

 

 

IRBMED has updated the Informed Consent Templates pages on our website in order to provider easier navigation between the Standard ICD Template and the newly added Specialty Templates. 

 

 

 

To access the main Consent Templates page, click here

 

 

 

To access the new specialty consent templates directly, click here

 

 

 

January 9, 2014 — U-MIC Update 

 

 

 

The previous U-MIC presentation offered recommendations for creating effective informed consent documents. This instructional follow-up presentation applies these principles in the revision of a problematic consent passage. 

 

 

 

November 21, 2012 —

 

 

 

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 irbmed@umich.edu – or see Guidance for Blinded Studies (hotlink).